BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL SR

    MDR report key: 2486300 · Received March 9, 2012

    Report

    Report Number
    2017865-2012-01294
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    December 16, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED. THE PATIENT HAD BEEN LOST TO FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5610 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR