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Related Experiment Videos

Multiple adverse events with a dual chamber pacemaker.

M Glikson1, O Gurevitz, E Yaacobi

  • 1Heart Institute, Tel-Aviv University, Sheba Medical Center, Tel Hashomer, Israel. mglikson@post.tau.ac.il

Pacing and Clinical Electrophysiology : PACE
|July 6, 2000
PubMed
Summary
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The Physiocor 400T pacemaker experienced significant adverse events, including spontaneous reversion and unexpected battery depletion. These findings suggest elective replacement of remaining units due to potential risks.

Area of Science:

  • Cardiology
  • Biomedical Engineering

Background:

  • Dual chamber pacemakers are crucial for managing bradyarrhythmias.
  • The Physiocor 400T is a specific model requiring evaluation for long-term performance.

Purpose of the Study:

  • To assess the clinical performance and safety of the Physiocor 400T dual chamber pacemaker.
  • To identify and quantify adverse events associated with this pacemaker model.

Main Methods:

  • Retrospective analysis of 63 Physiocor 400T pacemaker implants.
  • Follow-up of patients for an average of 46 months to record device behavior and patient outcomes.

Main Results:

  • 19% of patients experienced adverse events, including spontaneous reversion (9.5%), unexpected battery depletion (5%), and loss of telemetry (1.6%).

Related Experiment Videos

  • Estimated 5-year event-free survival was 46%, indicating a notable rate of device-related complications.

    • Conclusions:

    • The Physiocor 400T pacemaker demonstrated a concerning rate of adverse events, particularly asynchronous pacing and premature battery depletion.
    • Elective replacement of all remaining Physiocor 400T units is recommended to mitigate patient risk.