BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1052625 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-02806
    Event Type
    Injury
    Date Received
    May 27, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P860001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, SINCE IMPLANT, THE PT HAS EXPERIENCED ISSUES WITH HER ARMS (UNSPECIFIED), CLUSTER HEADACHES AND SEIZURES. THE PT HAS HAD SUCCESS WITH THE THERAPY TREATING THE BACK PAIN FOR WHICH IT WAS IMPLANTED. AN X-RAY PERFORMED SHOWED NO ISSUE WITH THE DEVICE. THE MIGRAINE HEADACHES APPEARED TO STOP WHEN THE STIMULATION DEVICE WAS OFF. TROUBLESHOOTING WAS BEING CONSIDERED. ADDITIONAL INFO 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 RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY MODEL 37752| EXPLANTED:| PROGRAMMER MODEL 37742| IMPLANTED:| LEAD MODEL 39565| EXTENSION MODEL 37081| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 37081| EXPLANTED:| IMPLANTED: