BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1022030 · Received March 31, 2008

    Report

    Report Number
    6000153-2008-01693
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    December 12, 2007
    Report Date
    February 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED MANIAC PSYCHO-MOTOR AGITATION AND DYSKINESIA FIFTEEN MINUTES AFTER THE NEUROSTIMULATOR WAS TURNED ON. IT IS UNKNOWN AS TO WHY THE NEUROSTIMULATOR HAD BEEN TURNED OFF. THE PRODUCT WILL NOT BE EXPLANTED. THE HCP INTENDS TO MANAGE THE ADVERSE EVENT. THE PATIENT OUTCOME IS UNKNOWN. REFER TO MEDWATCH REPORT# 6000153-2008-01694. THE PATIENT HAS BEEN ENROLLED IN A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3389 J0444095V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU068400V| EXTENSION MODEL 7482 LOT# NHU068402V