BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 1896998 · Received November 11, 2010

    Report

    Report Number
    2017865-2010-05333
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    August 2, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AT THE END OF PULSE GENERATOR INTERROGATION, THE PSA WAND WAS REMOVED AND THE PATIENT'S INTRINSIC RATE WAS 100 BPM. ONE MINUTE LATER, IT APPEARED THAT THE DEVICE BEGAN TO PACE AT A FREQUENCY OF 50 BPM. WHEN THE WAND WAS RE-APPLIED, THE DEVICE STOPPED PACING. THE EVENT COUNTER SHOWED ZERO ATRIAL SENSED-VENTRICULAR PACED SHARES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5816 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR