BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2102694 · Received May 19, 2011

    Report

    Report Number
    3007566237-2011-03669
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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, DURING A STAGE-2 DEEP BRAIN STIMULATION (DBS) IMPLANT, THE PT'S LEAD WAS DAMAGED. THE LEAD END CAP THAT WAS USED APPEARED TO HAVE CAUSED DAMAGE TO THE LEAD. IT WAS SUSPECTED THAT A SCREW MAY HAVE BEEN OVER-TIGHTENED ON THE CAP. THE SCREW "DISAPPEARED." THE WIRES FROM THE FIRST CONTACT ON THE LEAD WERE BROKEN AND THERE WAS A KINK BETWEEN THE SECOND AND THIRD CONTACTS OF THE LEAD. NO PT SYMPTOMS OR INJURY WERE REPORTED. ADDITIONAL INFO WAS REQUESTED, BUT NOT YET RECEIVED, AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK