BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2141139 · Received June 22, 2011

    Report

    Report Number
    3007566237-2011-04665
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS MOVED BECAUSE THE LOCATION RESTRICTED THE PT'S MOVEMENT WHEN BENDING. THE DEVICE WAS MOVED FROM THE PT'S FRONT RIGHT-SIDE, AT THE WAISTLINE, TO JUST BELOW THE WAISTLINE ON THE LEFT-SIDE BUTTOCK. THIS ALLOWED FOR "IDEAL" FLEXIBILITY FOR THE PT. THE PT HAD DIFFICULTY "SETTING THE INSTRUMENT UP" AFTER THE DEVICE WAS MOVED INTO THE NEW LOCATION. THE PT DID NOT HAVE AN ANTENNA FOR THE PROGRAMMER. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROGRAMMER: MODEL 37744, LOT# UNK