BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1994282 · Received January 14, 2011

    Report

    Report Number
    3007566237-2011-00391
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 5, 2010
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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 PT FELT SHOCKING ALL OVER HIS BODY WHEN HE USED THE PT PROGRAMMER TO ADJUST STIMULATION. THIS OCCURRED WHEN HE CHANGED ANY PARAMETER OR SIMPLY TURNED THE IMPLANTABLE NEUROSTIMULATOR ON OR OFF. THE SHOCKING OCCURRED WITH AND WITHOUT THE PROGRAMMER ANTENNA. MOVEMENT DID NOT CAUSE STIMULATION CHANGES. STIMULATION FELT 'EXTERNAL' ON HIS BODY VERSUS BEING INTERNAL. THE DEVICE WAS RECENTLY IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 37743, LOT# UNK| IMPLANTED:| EXPLANTED: