Key result
Evaluation of the CPI Model 0505 programmable pacemaker in 15 patients revealed 3 instances of sudden pacemaker failure (20%) traced to a timing crystal malfunction.
Why the study?
What is the clinical experience and safety profile of the CPI Model 0505 programmable pacemaker?
Observational (n=15)
What is the clinical experience and safety profile of the CPI Model 0505 programmable pacemaker?
Early clinical experience with the CPI Model 0505 programmable pacemaker identified a hardware failure related to a timing crystal, which was subsequently corrected.
Alerts clinicians to sudden failure risk with CPI Model 0505 pacemakers; leaves open generalizability to other early programmable devices.
As part of a study to evaluate a new programmable pacemaker, 15 patients received lithium-powered R-wave inhibited, unipolar pulse-generators (CPI Model 0505). Five were initial implants (Group I) and 10 were pulse generator replacements (Group II). The follow-up period ranged from 1 to 18 months (mean 11 months). There were 5 deaths unrelated to the pacemaker. Three instances of pacemaker failure were identified and were characterized by a sudden loss of pacemaker output. THe malfunction, traced to a 10 kHz timing crystal, has been corrected in subsequently manufactured pulse-generators. In 11 patients, the pacemakers were programmed at a pulse width which was twice the threshold determined at 3 months. Four were programmed at 0.1 ms, three at 0.2 ms and four at 0.4 ms. Although no complications were seen in patients programmed at 0.1 ms pulse width, it might be advisable to leave pacemakers at 0.2 ms or greater for chronic pacing in patients with a pulse width threshold at 0.05 mg.
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MacGREGOR et al. (1980) conducted an observational in Indication for pacemaker implantation (n=15). Programmable pacemaker (CPI Model 0505) was evaluated on Pacemaker failure. Evaluation of the CPI Model 0505 programmable pacemaker in 15 patients revealed 3 instances of sudden pacemaker failure (20%) traced to a timing crystal malfunction.
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