BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY XL DR

    MDR report key: 4191734 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04559
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 2, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND THE DEVICE EXHIBITED BACKUP VVI OPERATION DUE TO MULTIPLE FLIPPED BITS IN THE PRODUCT CODE. AFTER THE PRODUCT CODE WAS DOWNLOADED, NORMAL FUNCTION RESUMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR HAD NO TELEMETRY. THE DEVICE DISPLAYED SOFTWARE ERROR MESSAGE AND STOPPED PACING. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28342 IDENTITY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CRMD 5376

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention