BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 3925693 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15607
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AND THE PULSE GENERATOR WAS FOUND IN BACKUP VVI MODE. A HARDWARE ELECTIVE REPLACEMENT INDICATOR WAS CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014 DUE TO A NORMAL ELECTIVE REPLACEMENT INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404858 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention