BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1170825 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05754
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED, THE PT WAS TOLD THAT THERE WAS SOMETHING WRONG WITH AN ELECTRODE. ADD'L INFO HAS BEEN REQUESTED. A F/U 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 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION: MODEL 7489 LOT# NHU001593V IMPLANTED| EXPLANTED| PROGRAMMER: MODEL 7435 LOT# NFT062510P| EXPLANTED| LEAD: MODEL 3998 LOT# LA1649 IMPLANTED| EXTENSION: MODEL 7489 LOT# NHU001597V IMPLANTED| EXPLANTED