BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1022458 · Received March 31, 2008

    Report

    Report Number
    9614453-2008-01703
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    October 4, 2007
    Report Date
    February 28, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS REVEALED THE NEUROSTIMULATOR IS ELECTICALLY OKAY, HOWEVER, THERE IS A PUNCHOUT HOLE IN THE # 7 SETSCREW GROMMET. SIGNIFICANT FOREIGN MATERIAL IN THE CONNECTOR PORT AROUND THE # 7 CONNECTOR AREA MAY INDICATE THAT THE PUNCHOUT HOLE OCCURRED PRIOR TO EXPLANT. THIS MAY BE RELATED TO THE REPORTED EVENT IF THE # 7 ELECTRODE WAS ACTIVE. THE INITIAL REVIEW FROM THE DEVICE SHOWS THAT THE # 7 ELECTRODE WAS POSITIVE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATED THE PT FELT UNCOMFORTABLE WITH THE NEUROSTIMULATOR. THE PT EXPERIENCED A FEELING OF WARMTH AROUND THE DEVICE AND THE FEELING OF "CONSTANT CURRENT THROUGH HER BODY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC SWISS MANUFACTURING FACILITY 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention