BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 3925337 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08948
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    July 22, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVAL DESCRIPTION: THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET. AFTER A PRODUCT CODE DOWNLOAD, NORMAL FUNCTION RESUMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEPENDENT PT PRESENTED TO THE CLINIC FOR A FOLLOW UP VISIT. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38264 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CRMD 5810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention