BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1140626 · Received August 28, 2008

    Report

    Report Number
    2182207-2008-05293
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    POSITIONING DIFFICULTIES WITH THE TRIAL LEAD WAS REPORTED. UNSPECIFIED IMPEDANCES WITH SEVERAL SNAP LID CONNECTORS AND EXTERNAL NEUROSTIMULATORS WAS ALSO REPORTED. THE IMPEDANCE MEASUREMENTS WERE NOT PROVIDED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3874