BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1936209 · Received December 14, 2010

    Report

    Report Number
    3007566237-2010-10453
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    RECEIVED INFO REPORTING THE ELECTRODE FOR THE RIGHT HEMISPHERE WAS MISPLACED AND POSITION OF THE LEAD NEEDED TO BE CORRECTED. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention