BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1162263 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05813
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 13, 2007
    Report Date
    August 19, 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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT DEVICE REPLACEMENT SURGERY FOR THE NEUROSTIMULATOR. THE DEVICE BATTERY REPORTEDLY DIED FAST FOR THE PATIENT'S RECORDED USAGE. THE DEVICE WAS IN PLACE FOR APPROXIMATELY 28 MONTHS. THE PT'S SETTINGS WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention EXTENSION: MODEL 7489| EXPLANTED:| PROGRAMMER MODEL 7435| LEAD: MODEL 3891| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| LEAD: MODEL 3891| EXPLANTED: