BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTIFY XL DR

    MDR report key: 4121569 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07704
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 18, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION. FINAL ANALYSIS COULD NOT CONFIRM PREMATURE BATTERY COMPLETION. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. BACKUP VVI OPERATION WAS DUE TO MULTIPLE BIT FLIPS IN THE PRODUCT CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BATTERY HAD EXHIBITED PREMATURE BATTERY DEPLETION AND BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32370 IDENTIFY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP LWP ST. JUDE MEDICAL, INC., CRMD 5376

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR