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Multiple pulse generator malfunctions with a dual chamber pacemaker.

Igor Lipchenca1, David Barlev, David Luria

  • 1Heart Institute, Sheba Medical Center, Tel Hashomer, Israel.

Pacing and Clinical Electrophysiology : PACE
|July 26, 2002
PubMed
Summary
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The Sorin Biomedica Minidual 50 pacemaker experienced significant malfunctions, with over 10% failing completely. Researchers recommend replacing these devices due to unpredictable failure rates.

Area of Science:

  • Cardiology
  • Biomedical Engineering
  • Medical Device Evaluation

Background:

  • The Minidual 50 is a dual-chamber pacemaker.
  • Pacemaker reliability is crucial for patient health.
  • Previous data on the Minidual 50's long-term performance is limited.

Purpose of the Study:

  • To evaluate the clinical performance and reliability of the dual-chamber pacemaker Minidual 50.
  • To identify the incidence and characteristics of malfunctions associated with the Minidual 50.
  • To assess the long-term safety and efficacy of the Minidual 50 pacemaker.

Main Methods:

  • A retrospective analysis of 66 Minidual 50 pacemakers implanted between 1995 and 1998.
  • Follow-up duration averaged 33 months.
  • Kaplan-Meier survival analysis was used to predict malfunction-free survival.

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Main Results:

  • Total function loss occurred in 10.6% of units.
  • False threshold measurements (sensing/pacing) were observed in 4.5% of patients.
  • Average time to malfunction was 37 months; failures were unpredictable and unrelated to battery status.
  • Predicted 4-year malfunction-free survival was 70%.

Conclusions:

  • The Minidual 50 pacemaker exhibits a high rate of unpredictable malfunction.
  • The study recommends replacing all remaining Minidual 50 units, especially in pacemaker-dependent patients.
  • Further investigation into the causes of Minidual 50 failure is warranted.