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(Circulation. 2005;112:2040-2042.)
© 2005 American Heart Association, Inc.

Special Reports

Lessons From the Failure and Recall of an Implantable Cardioverter-Defibrillator

From the Hypertrophic Cardiomyopathy Center of the Minneapolis Heart Institute Foundation, Minneapolis, Minn.

Correspondence to Robert G. Hauser, MD, Hypertrophic Cardiomyopathy Center, Minneapolis Heart Institute Foundation, 920 E 28th St, Minneapolis, MN 55407. E-mail rhauser747@aol.com

Key Words: death, sudden • defibrillation • defibrillators, implantable

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
Multiple clinical trials have shown that a properly functioning implantable cardioverter-defibrillator (ICD) is capable of interrupting sudden death caused by ventricular tachyarrhythmias. Unfortunately, ICDs are complex medical devices, and they do not always perform as expected. For example, only 5% of ICD batteries last >7 years, and most dual-chamber ICD models must be replaced for battery depletion every 3 to 5 years.¹ Normal battery depletion, however, is reliably predicted by routine follow-up methods before an ICD fails. In contrast, electronic malfunctions are unpredictable and may not be detected by standard follow-up techniques before an ICD is unable to deliver effective therapy. Thus, sudden cardiac arrest or death may be the first and only sign that an ICD has failed.²

Recently, we reported the death of a 21-year-old patient who received a Prizm 2 DR model 1861 ICD pulse generator (Guidant, Inc) in 2001 to prevent sudden cardiac death resulting from hypertrophic cardiomyopathy.³ In March 2005, this young man experienced a witnessed arrest and could not be resuscitated. His ICD was returned to Guidant, which found that the device had failed during the delivery of a shock. The cause of failure was massive electronic damage caused by electrical overstress that occurred when a short circuit developed between a high-voltage wire and a tube used to test the housing during manufacturing (see the Figure). At the time of our patient’s death, Guidant had knowledge of 25 similar Prizm 2 DR model 1861 failures in patients, 3 of whom had required rescue . . . [Full Text of this Article]

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