BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR, DF4 CONNECTOR

    MDR report key: 3090108 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01156
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    December 3, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND WAS FOUND TO BE NORMAL THE ORIGINAL BATTERY WAS SENT THE VENDOR FOR FURTHER EVALUATION AND AN INTERNAL BATTERY ANOMALY WAS FOUND THAT CAUSED THE REPORTED PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192079 CURRENT PLUS VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention