BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2030909 · Received March 4, 2011

    Report

    Report Number
    3007566237-2011-01648
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT, AND THERE WERE HIGH IMPEDANCES. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 4000 OHMS ON SOME OF THE BIPOLAR PAIRS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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