BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL DR

    MDR report key: 3210616 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03375
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    January 4, 2013
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED NO COMMUNICATION WAS CONFIRMED AND WAS DUE TO LOW BATTERY VOLTAGE. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY; NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND AN INTERNAL BATTERY ANOMALY WAS FOUND TO CAUSE THE PREMATURE BATTERY DEPLETION THAT LED TO THE LOSS OF COMMUNICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310070 CURRENT ACCEL DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention