BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1098649 · Received August 5, 2008

    Report

    Report Number
    6000032-2008-04656
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IMPEDANCE READINGS >4000 OHMS WAS REPORTED ON ALL OR SOME OF THE BIPOLAR PAIRS. ELECTRODES 4-7 WERE NOT PROGRAMMED. THE NEUROSTIMULATOR WAS DEPLETED. THE DEVICE WAS REPLACED. IMPEDANCES WERE NORMAL. THE STIMULATION WAS SATISFACTORY TO THE PT POST-OPERATIVELY. REFER TO MFR REPORT # 6000032-2008-04655.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANTED| EXPLANTED| LEAD MODEL 3986ILC LOT#N23711A| EXTENSION MODEL 7496-66 LOT# YS0002122N| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7495-51 LOT#XR0065025N| IMPLANTED| LOT # NFE136321H| IMPLANTABLE NEURO STIMULATOR MODEL 7427| EXTENSION MODEL 7495-51 LOT#XR0067331N| IMPLANTED| IMPLANTED| LEAD MODEL 3986ILC LOT# N23711A| IMPLANTED| EXPLANTED| LEAD MODEL 3986 LOT# NAM002840N