BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 996473 · Received February 6, 2008

    Report

    Report Number
    2182207-2008-00615
    Event Type
    Injury
    Date Received
    February 6, 2008
    Report Date
    January 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GIL-ROBLES, ET AL. "NEUROSURGICAL TREATMENTS IN CHILDHOOD DYSTONIAS AND DYSKINESIAS" MOVEMENT DISORDERS: REV NEUROL 2006; 43 (SUPL 1): S169-S172. THE ARTICLE DISCUSSED 121 PATIENTS WITH BILATERAL DEEP BRAIN STIMULATION OF GPI FOR DYSTONIA AND DYSKINESIAS. REPORTABLE EVENT: REGARDING 11 MECHANICAL COMPLICATIONS, THERE WAS 1 LEAD BREAKAGE. SPECIFIC DETAILS WERE 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 YR Required Intervention IMPLANTABLE LEADS MODEL UNK| IMPLANTABLE EXTENSIONS MODEL UNK| IMPLANTABLE STIMULATORS MODEL UNK