BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1915540 · Received November 5, 2010

    Report

    Report Number
    3007566237-2010-08918
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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

    IMPEDANCE MEASUREMENTS WERE REPORTED TO HAVE BEEN GREATER THAN 4000 OHMS, IN REGARDS TO A PT'S DEVICE. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. NO FURTHER INFO WAS PROVIDED, INCLUDING THE PT'S STATUS/OUTCOME. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC NEUROMODULATION 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1