BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1041269 · Received May 9, 2008

    Report

    Report Number
    6000153-2008-02523
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    April 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A SHOCKING OR JOLTING SENSATION AFTER A FALL. X-RAY REVEALED THE LEAD HAD MIGRATED. THE REST OF THE DEVICE SYSTEM REMAINED INTACT. THE PT WILL BE REIMPLANTED BUT REVISION SURGERY HAD NOT YET BEEN SCHEDULED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF ADDITIONAL INFO BECOMES AVAILABLE. REFER TO MEDWATCH REPORT #6000153-2008-02523.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J0424970V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE NEUROSTIMULATOR MODEL 7428| EXPLANTED| LEAD MODEL 3387 LOT# J0235460V| LOT# NFD100434H| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU057219V| IMPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT# NHU052753V| EXPLANTED