BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 3223236 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04936
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 28, 2013
    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
    CA
    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 FOLLOWING A POCKET REVISION PROCEDURE, THE PULSE GENERATOR EXHIBITED BACKUP OPERATION. THE DEVICE HAD BEEN EXPOSED TO CAUTERY. AFTER A DEVICE SOFTWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321656 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR