BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2100654 · Received May 12, 2011

    Report

    Report Number
    3007566237-2011-03460
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 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

    PT CODE: (B)(4) - LABELED NA. DEVICE CODE: (B)(4) - LABELED YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, THE LOCKING MECHANISM WHICH IS PLACED IN THE BURR HOLE IN THE SKULL TO LOCK THE DEEP-BRAIN STIMULATION LEAD INTO PLACE WOULD NOT LOCK, AND THE LEAD SUBSEQUENTLY MOVED DEEPER THAN INTENDED. THE LEAD WAS RETRACTED TO THE INTENDED DEPTH, AND THE HEALTH CARE PROVIDER WAS EVENTUALLY ABLE TO GET THE MECHANISM TO LOCK. IT WAS STATED THE LOCKING MECHANISM COULD NOT BE REPLACED DUE TO FEAR OF FURTHER DISLODGING THE LEAD. IT WAS STATED THAT, AT THE END OF THE PROCEDURE, THERE WAS GOOD LEAD PLACEMENT, AND THE LEAD WOULD BE CHECKED TO MAKE SURE THERE WAS NO FURTHER MOVEMENT. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1