BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1231165 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07396
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PUSHED HARD AND KNOCKED HER IMPLANTABLE NEUROSTIMULATOR AGAINST A DOOR HANDLE. THE AREA AROUND THE NEUROSTIMULATOR SWELLED UP AND SHE IMMEDIATELY LOST STIMULATION SENSATION. COMMUNICATION BETWEEN THE PT PROGRAMMER, RECHARGER AND NEUROSTIMULATOR WAS LOST. APPROX 1.5 MONTHS LATER, THE PT WAS SEEN IN CLINIC. THE DEVICE COULD NOT BE INTERROGATED. A PHYSICIAN MODE RECHARGE WAS ATTEMPTED WITHOUT SUCCESS. THE DEVICE WAS UNABLE TO BE PROGRAMMED WITH AN ULTRA PROGRAMMER. THE HCP WAS CONSIDERING DEVICE EXPLANT. THE PT STATUS WAS REPORTED AS 'FAIR'. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 3004209178-2008-07397.

    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 38 YR EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777| EXPLANTED:| RECHARGER: MODEL 37752| EXPLANTED:| LEAD: MODEL 3777| LEAD: MODEL 3777| IMPLANTABLE NEURO STIMULATOR: MODEL 37711| LOT # NJH717163H| EXPLANTED:| LEAD: MODEL 3777| PROGRAMMER: MODEL 37742