BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2061790 · Received March 30, 2011

    Report

    Report Number
    3007566237-2011-02411
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A DEEP BRAIN STIMULATION SURGERY, THE HEALTH CARE PROVIDER (HCP) REMOVED THE STYLET A LEAD. THE HCP TRIED TO REINSERT THE STYLET IN TO THE LEAD TO ADJUST THE LEAD PLACEMENT, BUT WAS UNABLE TO REINSERT THE STYLET. NO PATIENT OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1