BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 3923173 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14488
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS CONFIRMED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION AFTER BEING EXPOSED TO ELECTROCAUTERY. UPON REMOVING THE DEVICE FROM THE POCKET, LOSS OF PACING OCCURRED AFTER THE DEVICE SWITCHED TO UNIPOLAR PACING. THE DEVICE WAS PLACED BACK INTO THE POCKET TO REGAIN PACING SUPPORT. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400993 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR