BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2222735 · Received July 29, 2011

    Report

    Report Number
    3007566237-2011-05911
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    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

    IT WAS REPORTED THAT THE ELECTRODES WERE NOT OF EQUIDISTANT SPACING ON THE LEAD. THE DEVICE WAS NOT USED IN THE PT AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 0205103936

    Patients

    Seq Age Sex Outcome Treatment
    1