BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1101890 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04554
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    January 1, 2006
    Report Date
    July 1, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT FELL 2 YRS AGO AND HIS IMPLANTABLE NEUROSTIMULATOR STOPPED WORKING. THE DEVICE WAS TURNED OFF SINCE THE FALL. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AT THE AREA OF PARESTHESIA. A WIRE MAY HAVE MOVED. THE PT WAS AT HOME; HIS STATUS WAS UNDETERMINED. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L 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 Required Intervention EXPLANTED| EXTENSION MODEL 7496 LOT # UK6034965 IMPLANTED| LEAD MODEL 3586 LOT # LW0013322N IMPLANTED| PROGRAMMER MODEL 7435 LOT # NFT009613P| EXPLANTED