Sudden Pacemaker Failure

NADER ELMAYERGI, M.B., F.R.C.P.(C),* DAVINDER S. JASSAL, M.D., F.R.C.P.(C),*, SACH SINHA, F.R.C.P.(C),* KERRY LIEBRECHT, R.N.,* and COLETTE SEIFER, M.B., F.R.C.P. (U.K.)*
From the *Department of Cardiac Sciences, University of Manitoba, St Boniface General Hospital, Winnipeg, Manitoba, Canada; and Institute of Cardiovascular Sciences, St Boniface General Hospital, Winnipeg, Manitoba, Canada

Two cases of sudden pacemaker failure due to fractured wires supplying power to the generator are described. Both devices were Kappa KD703 (Medtronic Inc., Minneapolis, MN, USA) implanted in a prepectoral subcutaneous pocket. In 2002, Medtronic issued an advisory regarding Kappa 700/600 devices. A number of these devices, all subpectoral implants, had presented with intermittent or no output due to fractured wires supplying power to the devices, leading to recommendations to replace susceptible devices in pacemaker-dependent patients. These two cases may warrant extension of this advisory to include all these devices, regardless of implant location. (PACE 2009; 32:e4e6) pacing Cases An 88-year-old man received a dual-chamber permanent pacemaker, Kappa KD703 (Medtronic Inc., Minneapolis, MN, USA), in 2001 for symptomatic complete heart block. Medtronic leads, 5554 and 5054, were placed in the right atrium and right ventricle, respectively, and the device was placed in a left prepectoral subcutaneous pocket. The patient was subsequently followedup regularly in the pacemaker clinic. At his last visit in January 2007, the battery voltage was 2.75 V, impedance 1,070 an estimated 28- to 55month battery life on the device. On September 9, 2007, he developed sudden onset of dyspnea and profound weakness. He was found to be in complete heart block with a ventricular escape rate of 30 beats/minute, which progressed to ventricular standstill, requiring cardiopulmonary resuscitation, including intubation, ventilation and emergent temporary transvenous pacing. Interrogation of the device was unsuccessful as no communication could be established. Chest x-ray showed that the leads were in good position and there was no obvious evidence of lead fracture. The patient underwent successful replacement of the generator. At the time of the procedure, the atrial and ventricular leads were tested and both sensing and threshold characteristics were within normal parameters. The second case is a 79-year-old man who presented in 2001 with an anterior myocardial infarction (MI) complicated by symptomatic junctional bradycardia, requiring permanent pacing. A 4470 active xation lead (Guidant Corporation, Indianapolis, IN, USA) was positioned in the right atrium and a 1488TC lead (St. Jude Medical, Inc., St. Paul, MN, USA) lead in the right ventricle. A Kappa KD703 dual-chamber pulse generator was implanted also in a left prepectoral subcutaneous pocket. At the most recent clinic visit in October 2007, the battery voltage was 2.71 V, corresponding to an estimated 9- to 32-month battery life on the device. In February 2008, the patient presented following a syncopal episode. He was found to be in complete heart block with a ventricular escape rate of 30 beats/minute. A magnet was applied over the device with no effect. Device interrogation was unsuccessful as no communication could be established with the device. The patient underwent replacement of his pacemaker generator both atrial and ventricular leads demonstrated normal sensing and pacing characteristics. Both devices were returned to Medtronic, and subsequent testing conrmed the cause of sudden catastrophic device failure was due to fractured wires supplying power to the pacemaker. As documented, both of these devices were implanted in the left upper chest in a subcutaneous position. The original implants were done at separate institutions by different cardiologists. Discussion On March 15, 2002, Medtronic issued an advisory regarding Kappa 700/600 dual-chamber (DDD, DDDR, and VDD) implantable pulse

No disclosures/conicts to declare from any of the authors. Address for reprints: Colette Seifer, M.B., F.R.C.P. (U.K.), Assistant Professor, University of Manitoba, Staff cardiologist, St Boniface General Hospital, 409 Tache Avenue, Winnipeg, MB, Canada, R2H 2A6. Fax: 1-204-233-2157; e-mail: cmseifer@sbgh.mb.ca Received September 2, 2008; revised October 17, 2008; accepted October 24, 2008. doi: 10.1111/j.1540-8159.2009.02488.x 2009, The Authors. Journal compilation

2009 Wiley Periodicals, Inc.

e4

October 2009

PACE, Vol. 32

SUDDEN PACEMAKER FAILURE

Figure 1. Schematic of interconnections between battery and electronic circuitry in Kappa 700 pacemaker.

generators (IPGs; see http://www.medtronic. com/crm/performance/advisories/kappa600_70015mar2002.html). As of that date, 53 of 255,000 (0.02%) Kappa devices sold had observed failures. These devices had presented with an

electrical reset, intermittent output, or no output. Further investigation identied the cause as fractured wires supplying power to the pacemaker (Figure 1). According to Medtronic, these failures have been directly correlated to submuscular

Figure 2. Failure mode observed in the reported complaints is separation of interconnected wires between battery and electronic circuitry.

PACE, Vol. 32

October 2009

e5

ELMAYERGI, ET AL.

[e.g., subpectoral and abdominal] placement of these devices. These locations can result in additional stress and repetitive exing on the implanted device causing excessive fatigue on these wires (Figure 2). As of January 31, 2008, 286 out of approximately 180,000 (0.16%) Kappa family devices worldwide have been conrmed as having fractured power supply wires. Medtronic recommends pacemaker-dependent patients who have submuscular Kappa devices that have been designated as susceptible to wire fractures should be considered for replacement of the device. We present two cases of wire fracture resulting in clinically signicant events in patients in whom

the device was implanted subcutaneously. Both devices were in situ for approximately 7 years. An informal survey of 23 larger implant sites in Canada did not identify a similar case, but other makes and models have rarely manifest similar behavior. These cases appear to be sporadic. As of January 1, 2008, 41,000 of these Kappa devices remain implanted in the United States alone. It remains to be seen if further similar cases will occur. Regardless, consideration should be given to replacement of susceptible Kappa generators in pacemakerdependent patients, regardless of method of implantation.

e6

October 2009

PACE, Vol. 32