BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1051624 · Received May 21, 2008

    Report

    Report Number
    6000153-2008-02678
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    March 2, 2006
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A SURGICAL REPAIR OF HIS ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THE PATIENT SUFFERED SEVERE BRAIN DAMAGE AND/OR BURNS DUE TO THE USE OF ELECTROSURGICAL EQUIPMENT WHILE THE PATIENT'S DEEP BRAIN STIMULATOR LEFT TURNED ON. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE MANUFACTURER REPORT #: 6000153200802677.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J0537802V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S LOT# NFD102324H| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU103233V| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7428| IMPLANTED:| LEAD MODEL 3387 LOT# J0546774V| EXTENSION MODEL 7482 LOT# NHU095766V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: