BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1002560 · Received February 8, 2008

    Report

    Report Number
    3004209178-2008-00603
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 9, 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

    THE PT REPORTED THAT THE ALARM WENT OFF WHEN SHE WALKED THROUGH A THEFT DETECTOR. SINCE THEN, SHE HAD NOT FELT STIMULATION. THE MESSAGE SCREEN ON HER PT CONTROLLER SHOWED A 'CALL YOUR DOCTOR' ICON AND WAS IN A POWER ON RESET CONDITION. THE PT CALLED TECHNICAL SERVICES AND THE POWER ON RESET CONDITION WAS CLEARED USING THE PT PROGRAMMER.

    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 Required Intervention IMPLANTED| EXTENSION MODEL 7489 LOT#NHU044271V| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3777 LOT#V006259| LEAD MODEL 3777 LOT# V006259| ACCESSORY MODEL 37752 LOT#NKA018168N| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 37742 LOT#NJD020790N| EXPLANTED| EXPLANTED| IMPLANTED