BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 4091427 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-07796
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    April 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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. INTERROGATION INDICATED THAT THE DEVICE WAS IN ERI MODE. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO EXTENSIVE DAMAGE TO HEADER ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD BECAME STUCK IN THE HEADER OF PULSE GENERATOR AND THAT THE DEVICE HEADER BROKE OFF DURING CHANGEOUT. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34734 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5816

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR