BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1800902 · Received August 10, 2010

    Report

    Report Number
    3007566237-2010-06000
    Event Type
    Injury
    Date Received
    August 10, 2010
    Report Date
    July 13, 2010
    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

    A MAL-POSITIONED AND BROKEN LEAD WAS REPORTED. IN ADDITION, THE TWO LEAD WAS TWISTED. THE PATIENT'S SYMPTOM HAD NOT IMPROVED AFTER HAVING THE INITIAL IMPLANT SURGERY. THE LEAD WAS LATER REPLACED. FOLLOWING THE LEAD REVISION, THE PATIENT'S OUTCOME WAS 'WELL", AND THEIR SYMPTOM WAS UNDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention