BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2259612 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07699
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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

    IT WAS REPORTED THAT DURING AN INTRAOPERATIVE STAGE 2 PROCEDURE HIGH IMPEDANCE MEASUREMENTS OF >40000 OHMS WERE FOUND: C0 1487, C1 2602, C2 2472, C3 >40000, 01 3432, 02 3464, 03 >40000, 12, 13 >40000, 23 >40000. ALSO, THE FOLLOWING MEASUREMENTS WERE FOUND: C0 2295, C1 2513, C2 2603, C3 2447, 01 4160, 02 4600, 03 4479, 12 4462, 13 4629, 23 4489.

    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