BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1895592 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04385
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE WAS FOUND TO BE BELOW THE EXPECTED LIMITS. NO HIGH CURRENT DRAIN SOURCES WERE FOUND DURING BENCH, AUTOMATED ELECTRICAL, TEMPERATURE, AND HUMIDITY TESTING. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL BATTERY ANOMALY WAS FOUND TO CAUSE THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN THE CLINIC WITH DEVICE AT ERI. LONGEVITY ESTIMATION NOTED THAT THE DEVICE WAS EXPECTED TO LAST LONGER THAN OBSERVED. BATTERY VOLTAGE TREND IS REPORTEDLY SHOWING A RAPID DEPLETION. THE PATIENT REQUESTED NOT TO PERFORM ANY PROCEDURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention