Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators.
BACKGROUND
Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and longevity.


OBJECTIVE
The purpose of this study was to examine the performance of contemporary ICD pulse generators that failed or were replaced because of manufacturers recalls.


METHODS
ICD data were entered prospectively by nine participating centers. ICD pulse generator failure was defined as removal from service because the device was not functioning according to the manufacturer's specifications. A recalled ICD was a normally functioning pulse generator that was replaced as the result of a recall or advisory.


RESULTS
From 1998 to 2005, 1,220 ICDs failed and 135 were recalled and replaced. The average implant time of failed ICDs was 4.4 +/- 1.5 years and of recalled ICDs was 1.7 +/- 0.8 years. The average implant time of single- and dual-chamber ICDs with rate responsive or cardiac resynchronization (CRT-D) pacing capabilities was significantly shorter than the average implant time of single- or dual-chamber devices without these features (P <.001). ICDs that provided rate responsive or CRT-D pacing failed earlier because of battery depletion (P <.001) and were significantly more prone to unexpected electronic or housing failure (9% vs 5%, P = .008) and recalls (25% vs 1%, P <.0001). Major adverse events included death (n = 2), failure to convert ventricular tachyarrhythmias (n = 6), and inappropriate shocks (n = 11).


CONCLUSIONS
Based on our analysis of failed and recalled devices, the performance of contemporary ICDs has been adversely affected by premature battery depletion, electronic failure, and manufacturers' recalls. Additional studies are needed to precisely estimate ICD longevity and to determine the incidence of unexpected ICD failure.
Hauser
Robert G
RG
Minneapolis Heart Institute Foundation, Minnesota 55407, USA. rhauser747@aol.com
Hayes
David L
DL
Epstein
Andrew E
AE
Cannom
David S
DS
Vlay
Stephen C
SC
Song
Susan L
SL
Tyers
G Frank O
GF
D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal; D011211:Electric Power Supplies; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D006323:Heart Arrest / Q000517:prevention & control*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors