BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC

    MDR report key: 3621526 · Received October 30, 2013

    Report

    Report Number
    1627487-2013-00626
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Date of Event
    September 25, 2013
    Report Date
    October 8, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT ((B)(6)) IS W/O STIMULATION AND UNABLE TO ESTABLISH COMMUNICATION WITH THE IPG VIA THE PROGRAMMER. BASED ON THE PT'S PROGRAM SETTINGS, NORMAL BATTERY DEPLETION IS SUSPECTED, BUT IT CANNOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559041 EONC GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 3590352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK