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Pacemaker failures characterized by continuous direct current leakage.

J D Fisher, S Furman, B Parker

    The American Journal of Cardiology
    |June 1, 1976
    PubMed
    Summary
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    Direct current leakage in pacemaker output capacitors causes unexpected pulse generator failure. This previously unrecognized failure mode can occur without warning, impacting pacemaker reliability and patient safety.

    Area of Science:

    • Biomedical Engineering
    • Cardiology
    • Medical Device Technology

    Background:

    • Pacemaker pulse generator failures can significantly impact patient care.
    • Understanding failure mechanisms is crucial for improving device reliability.

    Observation:

    • Direct current leakage through output capacitors was identified as a cause of pulse generator failure.
    • This defect was found in multiple implanted and external pulse generators.
    • Leakage currents ranged from 0.14 to 0.26 milliamperes in implantable units.

    Findings:

    • The identified direct current leakage can lead to pacemaker implant failures.
    • Myocardial damage and electrode deterioration were observed in some cases.
    • Failures occurred unpredictably, sometimes within two weeks of normal function.

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    Implications:

    • This capacitor-related failure mode can be mistaken for primary battery failure.
    • Device monitoring programs may not predict these failures, necessitating a re-evaluation of diagnostic criteria.
    • Understanding this failure mechanism is vital for enhancing pacemaker design and maintenance protocols.