BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1800017 · Received August 12, 2010

    Report

    Report Number
    3007566237-2010-06049
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 13, 2010
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IMPEDANCES WERE READING >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. THEY WERE ABLE TO ADJUST PROGRAMMING AND CAPTURE THE PT'S PAIN. THE PT WAS GETTING STIMULATION AGAIN WITH THE NEW SETTINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1