Feasibility and initial results of an Internet-based pacemaker and ICD pulse generator and lead registry.
The medical community has no independent source of timely information regarding the performance of pacemaker and ICD pulse generators and leads. Accordingly, the authors established an Internet-based registry of pacemaker and ICD pulse generator and lead failures (www.pacerandicregistry.com). During the first year, they found three previously unreported device problems that were promptly communicated to the participants. Of the failures reported, 11% of ICD and 10% of pacemaker pulse generator failures were heralded by signs other than the expected elective replacement indicator (ERI). Average ICD battery longevity was 4.0 +/- 0.7 years, and average dual chamber pacemaker battery longevity was 6.8 +/- 2.6 years. Disrupted insulation accounted for 54% of pacemaker and 29% of ICD lead failures. Compared to pacemaker pulse generator and lead failure, ICD device failures were more likely to cause severe clinical consequences. In conclusion, an Internet-based registry is feasible and capable of providing timely data regarding the signs, causes, and clinical consequences of pacemaker and ICD failures.
Hauser
R
R
Minneapolis Heart Institute Foundation, 920 E. 28th St., Ste #300, Minneapolis, MN 55407, USA. rhauser747@aol.com
Hayes
D
D
Parsonnet
V
V
Furman
S
S
Epstein
A
A
Hayes
J
J
Saksena
S
S
Irwin
M
M
Almquist
A
A
Cannom
D
D
Gross
J
J
Kallinen
L
L
D002170:Canada; D003195:Computer Communication Networks; D017147:Defibrillators, Implantable; D004868:Equipment Failure / Q000706:statistics & numerical data; D019544:Equipment Failure Analysis; D005240:Feasibility Studies; D006801:Humans; D020407:Internet; D010138:Pacemaker, Artificial; D011358:Product Surveillance, Postmarketing; D012042:Registries / Q000706:statistics & numerical data; D014481:United States