BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1080280 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04232
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S GARAGE DOOR CLOSED, AND CAR ALARM WENT OFF AS HE WALKED BY THEM. FOLLOWING THE EVENT, THE NEUROSTIMULATOR WAS NOT RESPONDING TO THE PROGRAMMER AND THE PT LOST STIMULATION. THE PT WAS REPORTED TO BE AT HOME IN FAIR CONDITION. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 50 YR Required Intervention PROGRAMMER MODEL 7435 LOT#NFT061014P| LEAD MODEL 3988 LOT # N25400| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7495-66 LOT#XS0000245V| CONVERSION TYPE MODEL 3550-09 LOT# N0038795