BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2182320 · Received July 11, 2011

    Report

    Report Number
    3007566237-2011-05300
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED A SHORT BETWEEN ELECTRODES 10 AND 11 ON ONE LEAD IN THE PT'S DEEP BRAIN STIMULATION SYSTEM. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 LEAD: MODEL LEADMVD LOT# UNK| IMPLANTED:| EXPLANTED: