BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SMALL DBS EXTENSION

    MDR report key: 1800012 · Received August 12, 2010

    Report

    Report Number
    3007566237-2010-06061
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    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 THE DISTAL PART OF THE EXTENSION CARRIER BROKE OFF UNDER THE SKIN IN THE NECK/LOWER SKULL AREA. THE BROKEN PORTION WAS RETRIEVED BY NEUROSURGEON "WHEN HE CUT OFF AN EXTRA 5 CM". ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SMALL DBS EXTENSION MHY MEDTRONIC NEUROMODULATION 37085

    Patients

    Seq Age Sex Outcome Treatment
    1