BEUDAMED
    FDA Adverse Event Summary report: N

    EPIC PLUS DR

    MDR report key: 1895840 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04762
    Date Received
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED RESET WAS VERIFIED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY DEPLETION. BASED ON DEVICE SETTINGS, THE DEVICE DID NOT REACH THE EXPECTED LONGEVITY. NO HIGH CURRENT DRAIN SOURCES WERE FOUND THROUGHOUT BENCH, TEMPERATURE, HUMIDITY AND AUTOMATED ELECTRICAL TESTING. THE BATTERY WAS SENT TO THE MANUFACTURER FOR ANALYSIS. NO ANOMALIES WERE FOUND THAT COULD CAUSE PREMATURE DEPLETION. THE CAUSE OF THE BATTERY DEPLETION WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN RECEIVING FREQUENT VT EPISODES. DURING A FOLLOW-UP A RESET MODE WITH NO DEFIBRILLATION FUNCTION WAS OBSERVED. LEAD DAMAGE WAS SUSPECTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-239

    Patients

    Seq Age Sex Outcome Treatment
    1 1570/65 (B)(4)