BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION

    MDR report key: 1021110 · Received March 27, 2008

    Report

    Report Number
    2182207-2008-01600
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    December 3, 2007
    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

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    KISS ZH, DOIG-BEYAERT K, ELIASZIW M, TSUI J, HAFFENDEN A, SUCHOWERSKY O. THE CANADIAN MULTICENTRE STUDY OF DEEP BRAIN STIMULATION FOR CERVICAL DYSTONIA. BRAIN. 2007; 130(PT 11): 2879-2886. THIS ARTICLE DESCRIBES A STUDY INVOLVING BILATERAL GPI DEEP BRAIN STIMULATION IN 10 PTS WITH SEVERE, CHRONIC, MEDICATION-RESISTANT CERVICAL DYSTONIA. ONE PT WITH BILATERAL DBS FOR DYSTONIA DEVELOPED SHINGLES IN THE LEFT OPTHALMIC DIVISION OF THE TRIGEMINAL NERVE, AFTER HER FIRST LEAD SURGERY. THEREFORE, HER SECOND SIDE DBS IMPLANT WAS DELAYED BY ONE MONTH. A SMALL CHRONIC SUBDURAL FLUID COLLECTION WAS SEEN AT THE SECOND SIDE SURGERY AND DRAINED DURING THE PROCEDURE. THIS SAME PT HAD A VERY SUBTLE HEMIPARESIS (SEEN ONLY ON GAIT) THAT WAS PRESENT AT 6-MONTH FOLLOW-UP, BUT RESOLVED COMPLETELY BY 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL EXTENSION| EXPLANTED| PROGRAMMER MODEL PROGRAMMER| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO| LOT # UNK| EXPLANTED| LEAD MODEL 3387| EXTENSION MODEL EXTENSION