BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2201782 · Received August 5, 2011

    Report

    Report Number
    3007566237-2011-06109
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF EXTENSION MODEL 7482 SERIAL NUMBER (B)(4) DETERMINED THE # 0 AND 3 CONDUCTORS WERE BROKEN AT THE WELD. THE CONDUCTOR WAS BROKEN AT THE DISTAL END OF THE EXTENSION UP TO THE TRANSITION POINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S TREMOR INCREASED AND THE LEAD IMPEDANCE WAS CHECKED. ALL ELECTRODES SHOWED OVER 2000 OHMS. NO STIMULATION OCCURRED WHEN THE ELECTRODE SETTINGS WERE CHANGED. THE HCP SUSPECTED A FRACTURE AND AN X-RAY WAS TAKEN. THE EXTENSION FRACTURE WAS OBSERVED IN THE X-RAY, THE HCP DECIDED TO REPLACE. THE EXTENSION WAS REPLACED (B)(6) 2011.

    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 Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU200041V| EXPLANTED: