BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1230644 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07283
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    November 16, 2007
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS RESULTS OF THE IPG (MODEL 7427) AND THE PLUG WERE NORMAL. NO ANOMALY FOUND. THE EXTENSION ANALYSIS (MODEL 7495LZ) REVEALED CUT/MELTED INSULATION - NO SIGNIFICANT ANOMALIES. THE LEAD (UNKNOWN MODEL DUE TO IT BEING SEGMENTED) ANALYSIS INDICATED THE #0 CONDUCTOR WIRE WAS BROKEN (OVERSTRESS/DAMAGE). THE LEAD WAS STRETCHED AT THE #0 CONNECTOR AND THE #0 CONDUCTOR WAS BROKEN AT THE #0 CONNECTOR WELD SITE. ALL LEAD WIRES WERE CUT. ALL CONNECTORS WERE CRUSHED. THE DISTAL END WAS NOT RETURNED. THE LEAD BODY WAS SEGMENTED AND THE INSULATION WAS CUT THROUGH. THE PROXIMAL END WAS STRETCHED. NO COMMENT REGARDING THE LEAD WAS RETURNED WITH THE DEVICE. IT IS UNKNOWN IF ALL/SOME OF THE DAMAGE HAPPENED AT EXPLANT; THEREFORE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE NEUROSTIMULATOR DEVICE WAS RETURNED FOR DISPOSAL FOLLOWING NORMAL BATTERY DEPLETION. ANALYSIS INDICATED THE LEAD HAD BROKEN WIRES DUE TO OVERSTRESS/DAMAGE. IT IS UNKNOWN IF THE DAMAGE TO THE LEAD HAPPENED DURING EXPLANT. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 45 YR PROGRAMMER: MODEL 7435| LEAD: MODEL LEAD| EXPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495LZ