BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1111557 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04935
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO RECHARGE THE IMPLANTABLE NEUROSTIMULATOR, THE REGULAR RECHARGE SCREEN WAS SEEN, BUT NO CHARGE EFFICACY BOXES WOULD SHADE. AFTER THE NORMAL RECHARGE SCREEN WAS SEEN, THE REPOSITION ICON WOULD APPEAR. MULTIPLE RECHARGES WERE TRIED. THE PT HADN'T RECHARGE FOR ABOUT 2 MONTHS, BUT HAD PERFECT COUPLING UNTIL APPROX 1.5 MONTHS PRIOR TO THE COMPLAINT. THE PT LAST FELT STIMULATION SENSATION 3 WEEKS PRIOR TO THE COMPLAINT. THE PT FELL 1-2 TIMES A WEEK. IT LOOKED LIKE THE IMPLANTABLE NEUROSTIMULATOR HAD MIGRATED, BUT HAD NOT FLIPPED. THE IMPLANTABLE NEUROSTIMULATOR WAS SITUATED ABOUT 2 CM DEEP AND APPEARED TILTED, BUT NOT SEVERELY TILTED. THERE WAS MORE MOVEMENT IN THE POCKET, AND THE INCISION SITE WAS TENDER TO THE TOUCH. THE HCP WAS UNABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR AND PLANNED TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 39565| ACCESSORY MODEL 37752| EXPLANTED| EXTENSION MODEL 37081| EXPLANTED| EXTENSION MODEL 37081| EXPLANTED| PROGRAMMER MODEL 37742