BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 4192225 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04129
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, 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. EVAL DESCRIPTION: THE FIELD COMPLAINT COULD NOT BE VERIFIED. THE DEVICE SENSOR IS AUTOMATICALLY PROGRAMMED TO OFF WHEN THE DEVICE REACHES ERI. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED NO RATE MODULATED RESPONSE DURING ACTIVITY. DURING ANOTHER FOLLOW UP WHEN DEVICE IS INTERROGATED, ERI IS OBSERVED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32169 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CRMD 5810

    Patients

    Seq Age Sex Outcome Treatment
    1