BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1313093 · Received February 9, 2009

    Report

    Report Number
    1313093
    Event Type
    Malfunction
    Date Received
    February 9, 2009
    Date of Event
    November 20, 2008
    Report Date
    November 20, 2008
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NERVE STIMULATOR REMOVED - NOT FUNCTIONING. WIRES HAD COME OUT ONCE BEFORE & BEEN REINSERTED THEN ONE OUT AGAIN, DEVICE EXPLANTED YESTERDAY. ORIGINALLY IMPLANTED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNERGY NERVE STIMULATOR LGW

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR