BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABEL NEUROSTIMULATOR

    MDR report key: 1061482 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03252
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAS BEEN EXPERIENCING INCREASED BASELINE PAIN AND NOT HAVING THERAPEUTIC EFFECT SINCE THEY WERE INVOLVED IN A CAR ACCIDENT IN 2007. IT WAS REPORTED THE PT WAS PINNED IN THE CAR AND THE DEVICE WAS DAMAGED. THE LEADS HAVE "PULLED THROUGH THE MUSCLES" AND ARE NOT WORKING PROPERLY. IT WAS ALSO REPORTED THE DEVICE WILL NOT HOLD A CHARGE. THE PT WAS IN CONTACT WITH A HEALTH CARE PROVIDER AND EXPLANT, REVISION AND, TROUBLESHOOTING WERE BEING CONSIDERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EXPLANTED:| RECHARGER MODEL 37752| LEAD MODEL 3890| LEAD MODEL 3890| PROGRAMMER MODEL 37742| EXPLANTED:| EXTENSION MODEL 37082| EXPLANTED: