BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1005247 · Received February 29, 2008

    Report

    Report Number
    2182207-2008-00978
    Event Type
    Injury
    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. THERE WAS ONE POSTOPERATIVE SELF-LIMITING GRAND MAL SEIZURE REPORTED. TREATMENT AND OUTCOME INFO WAS NOT PROVIDED.

    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 Other STEREOTACTIC FRAME (NOT MEDTRONIC)| LEAD EXTENSION UNK (2)| LEAD UNK (N=1)| IPG UNK (N=1)| GUIDE TUBE (NOT MEDTRONIC)