BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1213063 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06826
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 24, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR STUCK BUTTON.

    Description of Event or Problem · 1

    THE PATIENT PROGRAMMER DISPLAYED THE STUCK BUTTON ERROR CODE AND WOULD NOT WORK. THE OFF BUTTON HAD NOT WORKED FROM THE BEGINNING. THE IMPLANTABLE NEUROSTIMULATOR WAS OFF AND THE PATIENT WAS IN A LOT OF PAIN. THE PATIENT DIDN'T WANT TO TURN THE DEVICE ON WITH THE RECHARGER BECAUSE THE STIMULATION SETTING WERE AT TOO HIGH FOR THE PATIENT TO TOLERATE. A NEW PROGRAMMER WAS ARRANGED TO BE DELIVERED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 90 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742| LEAD: MODEL 3999| EXTENSION: MODEL 37082| IMPLANTED: