BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1213785 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06736
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 23, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    APPROX TEN DAYS AGO, THE PT FELL ON HER BUTT. AFTER THE FALL, SHE WAS UNABLE TO GET THE STIMULATOR TO TURN OFF. THE PT CALLED 911 AND THEY CAME TO HER HOUSE, REVIEWED HER PT MANUAL, AND THEY WERE ABLE TO GET THE STIMULATOR TO TURN OFF. THE PT WAS AT HOME AT THE TIME OF THE CALL. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082| EXPLANTED:| RECHARGER: MODEL 37752| LEAD: MODEL 3999| PROGRAMMER MODEL 37742