BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1005080 · Received February 29, 2008

    Report

    Report Number
    2182207-2008-00979
    Event Type
    Death
    Date Received
    February 29, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: PATEL ET AL. "MAGNETIC RESONANCE IMAGING-DIRECTED METHOD FOR FUNCTIONAL NEUROSURGERY USING IMPLANTABLE GUIDE TUBES." NEUROSURGERY 2007; 61 (5, SUPPL 2): 358-366.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PATEL ET AL. "MAGNETIC RESONANCE IMAGING-DIRECTED METHOD FOR FUNCTIONAL NEUROSURGERY USING IMPLANTABLE GUIDE TUBES." NEUROSURGERY 2007; 61 (5, SUPPL 2): 358-366. THE ARTICLE DISCUSSES AN MRI-BASED STEREOTACTIC TECHNIQUE THAT IS CARRIED OUT UNDER GENERAL ANESTHESIA. A DIRECT TARGETING METHOD USING HIGH RESOLUTION MRI WITH AN IMPLANTABLE GUIDE TUBE THAT FACILITATES PERIOPERATIVE VERIFICATION OF TARGET LOCALIZATION AND THEN ACTS AS A CONDUIT TO DELIVER THE DBS LEAD. THE TECHNIQUE WITH THE GUIDE TUBE IS DESCRIBED ALONG WITH AN EVALUATION OF ITS USE ON 101 PTS. A NUMBER OF COMPLICATIONS WERE INCLUDED IN THE ARTICLE. THE GUIDE TUBE AND FRAME WERE NOT MANUFACTURED BY MEDTRONIC. ONE DEATH AS THE RESULT OF PULMONARY EMBOLISM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death IPG UNK (N=1)| STEREOTACTIC FRAME (NOT MEDTRONIC)| LEAD EXTENSION UNK (2)| GUIDE TUBE (NOT MEDTRONIC)| LEADMVD UNK (N=1)