BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2113823 · Received May 17, 2011

    Report

    Report Number
    3007566237-2011-03578
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE LEAD REVEALED THE DISTAL END OF THE LEAD WAS BENT. THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS BENT WHEN IT WAS TAKEN OUT OF THE BOX. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 0204806208

    Patients

    Seq Age Sex Outcome Treatment
    1