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Performance of a 3.2-mm to 6-mm adaptor
M W Sweesy1, R C Forney, S Erickson
1Robert L. Batey Cardiology Center, Pacemaker Systems Technology School, Bradenton, Florida 34209.
Pacing and Clinical Electrophysiology : PACE
|February 1, 1994
Summary
The 366-08 adaptor for pulse generators showed a high failure rate, with 8 of 14 devices failing. Failures were linked to the adaptor's mechanism, causing loss of capture and sensing issues.
Area of Science:
- Cardiovascular Medicine
- Biomedical Engineering
- Medical Device Technology
Background:
- The 366-08 adaptor is designed to connect a 3.2-mm bipolar lead to a 6-mm pulse generator.
- Implantable pulse generators are crucial for cardiac rhythm management.
Purpose of the Study:
- To evaluate the performance and failure rate of the 366-08 adaptor in patients.
- To identify the causes of adaptor failure and their clinical implications.
Main Methods:
- A cohort of 14 patients received implants incorporating the 366-08 adaptor.
- Device performance was monitored over an average follow-up period of 32.1 months.
- Failure analysis focused on clinical presentation and lead impedance measurements.
Main Results:
- Eight out of 14 implanted adaptors (57%) failed during the follow-up period.
- Failures were characterized by loss of capture and increased lead impedances.
- Some systems also exhibited loss of sensing, indicating significant device malfunction.
- The spring-loaded mechanism of the adaptor is the suspected cause of failure due to fatigue.
Conclusions:
- The high failure rate of the 366-08 adaptor necessitates consideration of prophylactic replacement in ventricular lead systems.
- Frequent monitoring of lead impedance may be an alternative strategy for early detection of potential failures.
- Further investigation into the durability of the adaptor's mechanism is warranted.