BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1180988 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06198
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    July 26, 2008
    Report Date
    September 8, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT'S STIMULATION SENSATION WAS LOST CAUSING THE PATIENT TO VISIT THE EMERGENCY ROOM. NO TREATMENTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT'S STIMULATOR HAD REACHED END OF LIFE AND NEEDED TO BE REPLACED. THE PATIENT HAD RELOCATED AND WAS IN THE PROCESS OF FINDING A NEW PHYSICIAN TO PERFORM THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention LEAD: MODEL 3487A| IMPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| EXTENSION: MODEL 7489| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A| EXPLANTED:| IMPLANTED: