BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1172111 · Received September 18, 2008

    Report

    Report Number
    3004209178-2008-05882
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION DEVICE WAS TURNING ON AT RANDOM TIMES AFTER THE PATIENT HAD TURNED IT OFF. THE PATIENT WOULD TURN THE DEVICE OFF BEFORE GOING TO BED AND AT SOME POINT THE DEVICE WOULD TURN BACK ON. THE PROBLEM WAS FIRST NOTED ABOUT TWO MONTHS AGO FOLLOWING A LEAD REVISION. SINCE THAT TIME "THE THERAPY HAS NOT WORKED WELL." IT WAS ALSO REPORTED THAT THE PATIENT HAS HAD TO RECHARGE THE DEVICE EVERY TWO DAYS. IT IS UNKNOWN HOW OFTEN THE PATIENT NORMALLY RECHARGES THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 58 YR ACCESSORY: MODEL 37752| LEAD: MODEL 3778| PROGRAMMER: MODEL 3742| EXPLANTED