VISIA AF MRI™

S VR SURESCAN™
Model DVFC3D4

Product specifications
Physical characteristics
Volumea 33 cm3
Mass 77 g
HxWxD 64 mm x 51 mm x 13 mm
Surface area of device can 57 cm2
Radiopaque IDb PFZ
Materials in contact with Titanium, polyurethane,
human tissuec silicone rubber

Battery chemistry
Hybrid CFx lithium/silver § MR Conditional with PhysioCurve™
vanadium oxide
Design
Battery model M945899A
a
b
Volume with connector ports unplugged.
The radiopaque ID and Medtronic radiopaque identifier can be viewed in a
§ SmartShock™ Technology
fluoroscopic image of the device.
c
These materials have been successfully tested for the ability to avoid biological
incompatibility. The device does not produce an injurious temperature in the
§ Complete Capture Management™
surrounding tissue during normal operation.
§ AF Diagnostics
Replacement indicators
< 2.73 V on 3 consecutive § DF4
Recommended
daily automatic
Replacement Time (RRT)
measurements
End of Service (EOS) 3 months after RRT

Maximum energy levels and typical full energy charge

times
Maximum programmed
35 J
energy
Maximum delivered energya,b 36 J
Maximum stored energyc 42 J
Typical charge time at
8.4 s
Beginning of Service (BOS)d
Typical charge time
at Recommended 12.5 s
Replacement Time (RRT)d
a
Energy delivered at connector block into a 50 Ω load.
b
For 35 J programmed energy, delivered energy exceeds 35 J.
c
Energy stored at charge end on capacitor.
d
Charge time during a nonwireless telemetry session may be slightly higher.
Device parameters Ventricular tachyarrhythmia therapy parameters
Parameter Programmable values
Tachyarrhythmia detection parameters
VF Therapy parameters
Parameter Programmable values
VF Therapy Status On ; Off
VF Detection On ; Off
Rx1-Rx2: 0.4; 0.6 … 1.8; 2;
VF Interval (Rate)a 240; 250 … 320 … 400 ms 3 … 16; 18; 20; 22; 24; 25;
12/16; 18/24; 24/32; 30/40 ; 26; 28; 30; 32; 35 J
Energy
VF Initial Beats to Detect 45/60; 60/80; 75/100; 90/120; Rx3-Rx6: 10; 11 … 16; 18;
105/140; 120/160 20; 22; 24; 25; 26; 28; 30;
32; 35 J
6/8; 9/12; 12/16 ; 18/24;
VF Beats to Redetect AX>B; B>AX
21/28; 24/32; 27/36; 30/40
Pathwaya Rx1-Rx4: B>AX ;
FVT Detection Off ; via VF; via VT Rx5-Rx6: AX>B
FVT Interval (Rate) a
200; 210 … 240 … 600 ms During Charging ;
ATP
VT Detection On; Off Before Charging; Off
VT Interval (Rate)a 280; 290 … 360 … 650 ms Deliver ATP if last 8 R-R ≥ 200; 210 … 240 … 300 ms
VT Initial Beats to Detect 12; 16 … 52; 76; 100 Therapy Type Burst ; Ramp; Ramp+
VT Beats to Redetect 8; 12 … 52 ChargeSaver™ On ; Off
VT Monitor Monitor ; Off Switch when number
VT Monitor Interval (Rate)a 280; 290 … 450 … 650 ms of consecutive ATP 1 ; 2; 3; 4; 6; 8; 10
successes equals
Monitored VT Beats to 16; 20; 24; 28; 32 … 56; 80;
Detect 110; 130 Smart Mode On ; Off
Wavelet VT/FVT Therapy parameters
Waveletb On ; Off; Monitor VT Therapy Status On; Off
Template [date] FVT Therapy Status On; Off
Match Threshold 40; 43; 46 … 70 … 97% CV; Burst; Ramp; Ramp+
Therapy Type
Rx1: Burst ; Rx2-Rx6: CV
Auto Collection On ; Off
0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20;
SVT V. Limita 240; 250; 260 … 650 ms 22; 24; 25; 26; 28; 30; 32; 35 J
Other enhancements Energy VT Rx1-Rx2: 20 J
VT Rx3-Rx6: 35 J;
Stabilitya
Off ; 30; 40 … 100 ms
FVT Rx1-Rx6: 35 J
Onset Off ; On; Monitor
AX>B; B>AX
72; 75; 78; 81 ; 84; 88; 91; 94; Pathwaya Rx1-Rx4: B>AX ;
Onset Percent
97% Rx5-Rx6: AX>B
High Rate Timeout Burst therapy parameters
Off; 0.25; 0.5; 0.75 ; 1; 1.25; Initial # Pulses 1; 2 … 8 … 15
VF Zone Only 1.5; 1.75; 2; 2.5; 3; 3.5; 4; 4.5;
50; 53; 56; 59; 63; 66 … 84;
5 min R-S1 Interval = (%RR)
88 ; 91; 94; 97%
Off ; 0.5; 1; 1.5 … 5; 6; 7 … 20;
All Zones Interval Dec 0; 10 … 40 ms
22; 24; 26; 28; 30 min
1; 2 … 10
T-Wave On ; Off
# Sequences VT Therapies: 3 ;
RV Lead Noise On; On+Timeout ; Off FVT Therapies: 1
Timeout 0.25; 0.5; 0.75 … 2 min Smart Modeb On; Off
Sensitivity Ramp therapy parameters
0.15; 0.30 ; 0.45; 0.60; 0.90; Initial # Pulses 1; 2 … 8 … 15
RVc,d
1.20 mV
50; 53; 56; 59; 63; 66 … 84; 88;
a
The measured intervals are truncated to a 10 ms multiple (for example, 457 ms R-S1 Interval = (%RR)
becomes 450 ms). The device uses this truncated interval value when applying the 91 ; 94; 97%
programmed criteria and calculating interval averages.
b
The Wavelet feature is automatically set to On when VF Detection is set to On. Interval Dec 0; 10 … 40 ms
c
This setting applies to all sensing in this chamber for both tachyarrhythmia detection
and bradycardia pacing operations. 1; 2 … 10
d
Carefully evaluate the possibility of increased susceptibility to EMI and oversensing
before changing the sensitivity threshold to its minimum (most sensitive) setting of # Sequences VT Therapies: 3 ;
0.15 mV. FVT Therapies: 1
Smart Modeb On; Off
 Ventricular tachyarrhythmia therapy parameters, cont’d. RV parameters
Parameter Programmable values Parameter Programmable values
Ramp+ therapy parameters 0.5; 0.75 … 1.25; 1.5; 1.75 …
RV Amplitude
Initial # Pulses 1; 2; 3 … 15 3.5 … 5.0; 5.5; 6.0; 8.0 V
50; 53; 56; 59; 63; 66 … 75 … 0.03; 0.06; 0.1; 0.2; 0.3;
R-S1 Interval = (%RR) RV Pulse Width
84; 88; 91; 94; 97% 0.4 … 1.5 ms
50; 53; 56; 59; 63; 66; 69 … 84; RV Sensitivitya 0.15; 0.3 ; 0.45; 0.6; 0.9; 1.2 mV
S1S2 (Ramp+) = (%RR)
88; 91; 94; 97% RV Pace Polarity Bipolar; Tip to Coil
50; 53; 56; 59; 63; 66 … 84; RV Sense Polarity Bipolar; Tip to Coil
S2SN (Ramp+) = (%RR)
88; 91; 94; 97% a
This setting applies to all sensing in this chamber for both tachyarrhythmia detection
and bradycardia pacing operations.
1; 2 … 10
# Sequences VT Therapies: 3 ; RV Capture Management™ parameters
FVT Therapies: 1
Parameter Programmable values
Smart Modeb On; Off
RV Capture Management Adaptive ; Monitor; Off
Shared Settings
RV Amplitude Safety Margin 1.5x; 2.0x ; 2.5x; 3.0x
V-V Minimum ATP Interval 150; 160 … 200 … 400 ms
RV Minimum Adapted
V. Amplitude 1; 2 … 6; 8 V 1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V
Amplitude
V. Pulse Width 0.1; 0.2 … 1.5 ms
RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days
V. Pace Blanking 150; 160 … 240 … 450 ms
Can+SVC On ; Can Off; SVC Blanking periods
Active Can™/SVC Coilc
Off
Parameter Programmable values
Progressive Episode
On; Off V. Blank Post VP 150; 160 … 200 … 450 ms
Therapies
V. Blank Post VS 120 ; 130 … 170 ms
Confirmation+ On ; Off
a
If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is
not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil Rate response pacing parameters
parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-
voltage delivery pathway. Parameter Programmable values
b
Smart Mode is available only for Rx1-Rx4.
c
The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency Upper Sensor Rate 80; 85 … 120 … 175 bpm
high-voltage therapies. It also applies to T-Shock™ inductions.
ADL Rate 60; 65 … 95 … 170 bpm
Rate Profile Optimization On ; Off
AF Detection parameters ADL Response 1; 2; 3 ; 4; 5
Exertion Response 1; 2; 3 ; 4; 5
AF detection parameters
Low; Medium Low ;
Parameter Programmable values Activity Threshold
Medium High; High
AF Detection Monitor ; Off Activity Acceleration 15; 30 ; 60 s
Least sensitive; Less sensitive; Activity Deceleration Exercise ; 2.5; 5; 10 min
AF Sensitivity Balanced sensitivity ;
ADL Set Point 5; 6 … 40; 42 … 80
More sensitive; Most sensitive
15; 16 … 40; 42 … 80;
Ectopy Rejection On ; Off UR Set Point
85 … 180
Episodes ≥ 6 min ;
Episiodes ≥ 10 min; Conducted AF response parameters
Record EGM for Episodes ≥ 20 min;
Episodes ≥ 30 min; Parameter Programmable values
Episodes ≥ 60 min Conducted AF Response On; Off
Response Level Low; Medium ; High
Pacing parameters Maximum Rate 80; 85 … 110 … 130 bpm

Modes, rates, and intervals Ventricular rate stabilization parameters

Parameter Programmable values Parameter Programmable values
Mode VVI ; VVIR; VOO; OVO V. Rate Stabilization On; Off
Lower Ratea 30; 35 … 40 ; 45 … 150 bpm Maximum Rate 80; 85 … 100 … 120 bpm
a
The corresponding Lower Rate Interval can be calculated as follows: Interval Increment 100; 110 … 150 … 400 ms
Lower Rate Interval (ms) = 60,000/Lower Rate.
Post VT/VF shock pacing parameters Number of Shocks Delivered in an Episodec
Parameter Programmable values Device Tone
Post VT/VF Shock Pacing On; Off Alert Enable – Urgency Off ; On-Low; On-High
Overdrive Rate 70; 75; 80 … 120 bpm Patient Home Monitor
0.5 ; 1; 2; 3; 5; 10; 20; 30; 60; Alert Enableb Off ; On
Overdrive Duration
90; 120 min
Shared (Device Tone and Patient Home Monitor)
Post shock pacing parameters Number of Shocks
1 ; 2; 3; 4; 5; 6
Thresholda
Parameter Programmable values
All Therapies in a Zone Exhausted for an Episode
Post Shock V. Amplitude 1; 2 … 6 ; 8 V
Device Tone
Post Shock V. Pulse Width 0.1; 0.2 … 1.5 ms
Alert Enable – Urgency Off ; On-Low; On-High
Sleep parameters Patient Home Monitor
Parameter Programmable values Alert Enableb Off ; On
a
This parameter is displayed only if an associated alert has been enabled.
Sleep On; Off b
Alerts are programmable and transmittable to a monitor only when Patient Home
Monitor is programmed to Yes.
30; 35 … 50 ; 55; 60; 70; c
Note that VF, VT, and FVT therapies could be delivered during a single episode (from
Sleep Rate
75 … 100 bpm initial detection until episode termination).

Bed Time 00:00; 00:10 … 22:00 … 23:50

Lead/Device integrity alerts
Wake Time 00:00; 00:10 … 07:00 … 23:50
Parameter Programmable values
MRI SureScan parameters RV Lead
Parameter Programmable values Device Tone
MRI SureScan On; Off Alert Urgencya Low; High
VOO (Asynchronous); RV Lead Integrity Enable On ; Off
MRI Pacing Mode
OVO (Off) RV Lead Noise Enable On ; Off
MRI Pacing Rate 60; 70; 75… 120 bpm Patient Home Monitor
RV Lead Integrity Enablec On ; Off
Additional pacing features
RV Lead Noise Enable c
On ; Off
Parameter Programmable values
Lead Impedance Out of Range
Rate Hysteresis Off ; 30; 40 … 80 bpm
Device Tone
Alert Urgencya Low; High
Medtronic CareAlert parameters ™ RV Pacing Impedance Enable On ; Off (Observation only)
RV Defibrillation
Clinical management alerts On ; Off (Observation only)
Impedance Enable
Parameter Programmable values SVC Defibrillation
On ; Off (Observation only)
AT/AF Burden and Rate Settings … Impedance Enableb
Device Tone Patient Home Monitor
Alert Urgencya High ; Low RV Pacing Impedance
Off; On
Enablec
AF Daily Burden Alert Enable Off (Observation only) ; On
RV Defibrillation
Avg. V. Rate During AF Off; On
Off (Observation only) ; On Impedance Enablec
Alert Enable
SVC Defibrillation
Patient Home Monitor Off; On
Impedance Enableb,c
AF Daily Burden Alert Enableb Off ; On Shared (Device Tone and Patient Home Monitor)
Avg. V. Rate During AF RV Pacing Impedance
Off ; On 200 ; 300; 400; 500 Ω
Alert Enableb Less than
Shared (Device Tone and Patient Home Monitor) RV Pacing Impedance
1,000; 1,500; 2,000; 3,000 Ω
AF Daily Burden 0.5; 1; 2; 6 ; 12; 24 hours/day Greater than
Avg. V. Rate During AF 90; 100 … 150 bpm RV Defibrillation
20 ; 30; 40; 50 Ω
Impedance Less than
Daily Burden for
0.5; 1; 2; 6 ; 12; 24 hours/day RV Defibrillation
Avg. V. Rate 100; 130; 160; 200 Ω
Impedance Greater than
 Lead/Device integrity alerts, cont’d. ±1; ±2; ±4; ±8 ; ±12; ±16;
EGM 3 Range
Parameter Programmable values ±32 mV
SVC Defibrillation EGM1 and EGM2 ; EGM1 and
20 ; 30; 40; 50 Ω
Impedance Less than EGM3; EGM1 and LECG; EGM2
Stored (Ventricular)
SVC Defibrillation and EGM3; EGM2 and LECG;
100; 130; 160; 200 Ω EGM3 and LECG
Impedance Greater than
Low Battery Voltage RRT EGM1 and LECG; EGM2 and
Stored (Atrial)
LECG ; EGM3 and LECG
Device Tone
Off ; On – 1 month; On – 3
Alert Enable – Urgency Off; On-Low; On-High Pre-arrhythmia EGM
months; On Continuous
Patient Home Monitor Device Date/Timed (enter time and date)
Alert Enable c
Off; On Off ; 0.5; 1; 2; 4; 8; 16; 24; 36;
Holter Telemetry
Excessive Charge Time EOS 46 hr
Device Tone
a
This EGM channel displays far-field signals.
b
An SVC electrode must be present for this configuration.
Alert Enable – Urgency Off; On-Low; On-High c
If Can to SVC is selected, the EGM Range is automatically set to ± 2 mV. The EGM
Range is automatically set to ± 8 mV for all other EGM Source options.
Patient Home Monitor d
The times and dates stored in episode records and other data are determined by the
Device Date/Time clock.
Alert Enablec Off; On
VF Detection Off, 3+ VF or 3+ FVT Rx Off
Device Tone System test parameters
Alert Enable Off; On-High
Patient Home Monitor System test parameters
Alert Enablec Off; On Parameter Selectable values
a
This parameter is displayed only if an associated alert has been enabled. Pacing Threshold Test parameters
b
If an SVC lead is not implanted, the alert will not sound.
c
Alerts are programmable and transmittable to a monitor only when Patient Home Monitor Test Type Amplitude; Pulse Width
is programmed to Yes.
Decrement after 2; 3 … 15 pulses
Shared parameters RV Pace Polarity Bipolar; Tip to Coil
Parameter Programmable values Mode a
VVI; VOO
Patient Home Monitor Yes; No Lower Rate 30; 35 … 60; 70; 75 … 150 bpm
Alert Time a
00:00; 00:10 … 08:00 … 23:50 RV Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V
a
This parameter is displayed only if an associated alert has been enabled. RV Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms

System test parameters, cont’d.

Parameter Selectable values
Data collection parameters
V. Pace Blanking 150; 160 … 450 ms
Data collection parameters Sensing Test parameters
Parameter Programmable values Modea VVI; OVO
LECG Source Can to SVC ; Can to RVcoil;
b
Lower Rate 30; 35 … 60; 70; 75 … 120 bpm
(Leadless ECG)a RVcoil to SVCb
Wavelet Test parameters
±1; ±2 ; ±4; ±8; ±12; ±16;
LECG Range (Leadless ECG) Match Threshold 40; 43 … 70 … 97
±32 mV
RVtip to RVcoil; RVtip to Mode a
VVI; OVO
EGM 1 Source
RVring Lower Rate 30; 35 … 60; 70; 75 … 120 bpm
±1; ±2; ±4; ±8 ; ±12; ±16;
a
The selectable values for this parameter depend on the programmed pacing mode.
EGM 1 Range
±32 mV
Can to RVcoil ; Can to
RVring; RVtip to RVcoil; RVtip
EGM 2 (Wavelet) Source
to RVring; Can to SVCb,c;
RVcoil to SVCb
±1; ±2; ±4; ±8; ±12 ; ±16;
EGM 2 (Wavelet) Range
±32 mV
RVtip to RVcoil; RVtip to
EGM 3 Source
RVring
EP study parameters Manual defibrillation parameters
Parameter Selectable values
T-Shock induction parameters
0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20;
Parameter Selectable values Energy
22; 24; 25; 26; 28; 30; 32; 35 J
Resume at Deliver Enabled ; Disabled Pathwaya AX>B; B>AX
Enable Enabled; Disabled a
If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not
used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter
#S1 2; 3; 4; 5 ; 6; 7; 8 is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery
pathway.
S1S1 300; 310 … 400 … 2,000 ms
Delay 20; 30 … 300 … 600 ms Manual cardioversion parameters
0.4; 0.6; 0.8; 1.0 … 1.8; 2; 3; Parameter Selectable values
Energy 4 … 16; 18; 20; 22; 24; 25; 26; 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20;
28; 30; 32; 35 J Energy
22; 24; 25; 26; 28; 30; 32; 35 J
Waveform Monophasic ; Biphasic Pathwaya AX>B; B>AX
Pathway a
AX>B; B>AX a
If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not
used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter
a
If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not
is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery
used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter
pathway.
is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery
pathway.
Shared manual ATP therapy parameters
50 Hz Burst induction parameters Parameter Selectable values
Parameter Selectable values Minimum Interval 150; 160 … 200 … 400 ms
Resume at Burst Enabled ; Disabled Amplitude 1; 2 … 6 ; 8 V
Amplitude 1; 2; 3; 4 ; 5; 6; 8 V Pulse Width 0.10; 0.20 … 1.50 ms
Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms Manual Ramp therapy parameters
Parameter Selectable values
Fixed Burst induction parameters
# Pulses 1; 2 … 6 … 15
Parameter Selectable values
50; 53; 56; 59; 63; 66 … 84; 88;
Resume at Burst Enabled ; Disabled %RR Interval
91; 94; 97 %
Interval 100; 110 … 600 ms Dec/Pulse 0; 10 ; 20; 30; 40 ms
Amplitude 1; 2; 3; 4 ; 5; 6; 8 V
Manual Burst therapy parameters
Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms
Parameter Selectable values
PES induction parameters # Pulses 1; 2 … 8 … 15
Parameter Selectable values 50; 53; 56; 59; 63; 66 … 84;
%RR Interval
88 ; 91; 94; 97%
Resume at Deliver Enabled ; Disabled
#S1 1; 2 … 8 … 15 Manual Ramp+ therapy parameters
S1S1 100; 110 … 600 … 2,000 ms Parameter Selectable values
S1S2 Off; 100; 110 … 400 …600 ms # Pulses 1; 2; 3 … 15
Off ; 100; 110 … 400; 410 … 50; 53; 56; 59; 63; 66 … 75 …
S2S3 R-S1 (%RR)
600 msa 84; 88; 91; 94; 97%
Off ; 100; 110 … 400; 410 … 50; 53; 56; 59; 63; 66; 69 …
S3S4 S1-S2 (%RR)
600 msa 84; 88; 91; 94; 97%
Amplitude 1; 2; 3; 4 ; 5; 6; 8 V 50; 53; 56; 59; 63; 66 … 84;
S2-SN (%RR)
Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms 88; 91; 94; 97%
a
Default value when parameter is On is 400 ms.
Longevity
Projected service life in years
The service life projections are based on the following
Projected service life in years assumptions:
§ Semi-annual maximum energy charging frequency
Pacing Mode, Pacing 500 Ω 600 Ω § Pre-arrhythmia EGM storage programmed to On for
percent pacing Amplitude pacing impedance pacing impedance a 6-month period (two 3-month follow-up intervals),
over the entire life of the device
2.5 V 11.0 11.0
VVI, 0% § 3 hours of wireless telemetry during implant
3.5 V 11.0 11.0 § A quarterly schedule of Medtronic CareLink™ monitor
2.5 V 10.7 10.8 remote transmissions
VVI, 15% § 1 hour of in-office wireless telemetry annually
3.5 V 10.4 10.5 § Typical shelf storage time before implant
2.5 V 10.1 10.2 Projected service life estimates are based on
VVI, 50%
3.5 V 9.2 9.5 accelerated battery discharge data and device modeling
as specified. Do not interpret these values as precise
2.5 V 9.3 9.6
VVI, 100% numbers.
3.5 V 7.9 8.3

Brief Statement
Visia AF MRI™ S VR DVFC3D4
The Visia AF MRI S VR SureScan™ ICD is MR Conditional and, as such is
designed to allow patients to be safely scanned by an MRI machine when
used according to the specified MRI conditions for use. When programmed
to On, the MRI SureScan feature allows the patient to be safely scanned
while the device continues to provide appropriate pacing. The Visia AF MRI
SureScan system automatically detects and records the occurrence of atrial
fibrillation (AF) for diagnostic purposes.
Indications for Use: The Visia AF MRI S VR SureScan system is indicated
to provide ventricular antitachycardia pacing and ventricular defibrillation
for automated treatment of life-threatening ventricular arrhythmias. A
complete SureScan defibrillation system is required for use in the MR
environment. A complete SureScan defibrillation system includes a Visia
AF MRI S VR SureScan ICD device with a SureScan defibrillation lead. To
verify that components are part of a SureScan system, visit http://www.
mrisurescan.com. Any other combination may result in a hazard to the
patient during an MRI scan.
Contraindications: The Visia AF MRI S VR SureScan ICD is contraindicated
for patients experiencing tachyarrhythmias with transient or reversible
causes including, but not limited to, the following: acute myocardial
infarction, drug intoxication, drowning, electric shock, electrolyte imbalance,
hypoxia, or sepsis; patients who have a unipolar pacemaker implanted,
patients with incessant VT or VF, and patients whose primary disorder is
atrial tachyarrhythmia.
Warnings and Precautions: Changes in patient’s disease and/or
medications may alter the efficacy of the device’s programmed parameters.
Patients should avoid sources of magnetic and electromagnetic radiation
to avoid possible underdetection, inappropriate sensing and/or therapy
delivery, tissue damage, induction of an arrhythmia, device electrical reset,
or device damage. Do not place transthoracic defibrillation paddles directly
over the device.
Patients and their implanted systems must be screened to meet the
following requirements for MRI: no implanted lead extenders, lead adaptors,
or abandoned leads; no broken leads or leads with intermittent electrical
contact as confirmed by lead impedance history; a SureScan defibrillation
system implanted in the left or right pectoral region; pacing capture
thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; no diaphragmatic stimulation
at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose
device will be programmed to an asynchronous pacing mode when MRI
SureScan is programmed to On.
Patients may be scanned using a horizontal field, cylindrical bore, clinical
1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial
gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis
≤ 200 T/m/s. 1.5T scanners must be operated in Normal Operating Mode
(whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR
≤ 3.2 W/kg). 3T scanners must be operated in First Level Controlled
Operating Mode or Normal Operating Mode. B1+RMS must be ≤ 2.8 μT when
the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be
performed without B1+RMS restriction when the isocenter is at or superior to
the C7 vertebra.
Continuous patient monitoring is required while MRI SureScan is
programmed to On. While MRI SureScan is programmed to On, arrhythmia
detection and therapies are suspended, leaving the patient at risk of death
from untreated spontaneous tachyarrhythmia. In addition, if the device
is programmed to an asynchronous pacing mode, arrhythmia risk may be
increased.
Potential Complications: Potential complications include, but are not
limited to, rejection phenomena, erosion through the skin, muscle or nerve
stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia
episodes, acceleration of ventricular tachycardia, and surgical complications
such as hematoma, infection, inflammation, and thrombosis. Potential MRI
complications for the SureScan system include, but are not limited to, lead
electrode heating and tissue damage resulting in loss of sensing or capture
or both, or induced currents on leads resulting in continuous capture, VT/
VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring
during the scan that is not detected and treated because tachyarrhythmia
detection is suspended while MRI SureScan is programmed to On; potential
for VT/VF induction when the patient is programmed to an asynchronous
pacing mode during MRI SureScan; device heating resulting in tissue
damage in the implant pocket or patient discomfort or both; or damage
to the functionality or mechanical integrity of the device resulting in the
inability of the device to communicate with the programmer.
See the MRI SureScan Technical Manual before performing an MRI Scan and
Device Manual for detailed information regarding the implant procedure,
indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at
1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com
or www.mrisurescan.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of
a physician.

Medtronic
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Minneapolis, MN 55432-5604
USA

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