BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1213776 · Received October 22, 2008

    Report

    Report Number
    6000032-2008-06742
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 24, 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

    THE PT NEEDED COVERAGE ON HER LEFT LOWER LEG. IMPEDANCES WERE CHECKED AND FOUND TO BE >4,000 OHMS ON MOST ELECTRODES; THE #0 ELECTRODE WAS REPORTED TO BE "DECENT". THE STIMULATOR WAS REPROGRAMMED. THEY WERE ABLE TO GET STIMULATION FOR THE PT IN HER LOWER LEG AS NEEDED; SHE HAD GOOD COVERAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR EXPLANTED:| LEAD: MODEL 3998| EXTENSION: MODEL 748925| IMPLANTED:| PROGRAMMER: MODEL 7435| EXTENSION: MODEL 748925| EXPLANTED:| IMPLANTED:| EXPLANTED: