ICD product reliability: Lessons from electrical overstress failures

PACE - Pacing and Clinical Electrophysiology

Volumn 24, Issue 7, 2001, Pages 1043-1045

  Swerdlow, Charles D ^a,c   Cannom, David S ^b  

^a MEDTRONIC INC   (United States)

^b BOSTON SCIENTIFIC CORPORATION   (United States)

^c NONE   (United States)

Author keywords

Defibrillator malfunction; Implantable cardioverter defibrillator; Postmarket surveillance

Indexed keywords

DEFIBRILLATOR; DEVICE; EDITORIAL; PHYSICIAN ATTITUDE; POSTMARKETING SURVEILLANCE; PROSTHESIS FAILURE; QUALITY CONTROL;

EID: 0034948078     PISSN: 01478389     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1460-9592.2001.01043.x     Document Type: Editorial

References (17)

1. Unexpected ICD failure due to electronic circuit damage caused by electrical overstress
2. High power circuitry
3. Inability to communicate with ICDs'. An underreported failure mode
4. Sensing lead insulation defect resulting in a damage of the ICD pulse generator case
5. Improving patient care by reporting problems with medical devices
6. Prospective postmarket device studies versus returned product analysis as a predictor of system survival
7. Estimating reliability of medical devices during the post-market surveillance phase
8. Exact confidence limits for p
9. ICD hardware failure associated with multiple internal shocks
10. FDA recalls: How do pacemaker manufacturers compare?
11. Management of intracardiac device recalls: A consensus conference. Participants of the Consensus Conference
12. Recommendations for implementation of a North American Multicenter Arrhythmia Device/Lead Database