BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 1823562 · Received August 27, 2010

    Report

    Report Number
    3007566237-2010-06522
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FIELD REP WAS UNABLE TO ADJUST STIMULATION. THE EXTERNAL NEUROSTIMULATOR DISPLAYED THE OUT OF REGULATION MESSAGE. TROUBLESHOOTING REVEALED THAT THE LEAD WAS IMPROPERLY SEATED IN THE SNAP LID CONNECTOR, PRODUCTING A SHORT. THE LEAD WAS RESEATED AND WORKED FINE. THE STIMULATION TRIAL WAS EXTENDED. THE PT DID WELL AND DECIDED TO PROCEED TO PERMANENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION ENS NA

    Patients

    Seq Age Sex Outcome Treatment
    1