BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1153088 · Received September 8, 2008

    Report

    Report Number
    2182207-2008-05531
    Event Type
    Injury
    Date Received
    September 8, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ALTERMAN RL, SNYDER BJ. DEEP BRAIN STIMULATION FOR TORSION DYSTONIA. ACTA NEUROCHIR SUPPL. 2007;97: 191-199. DEEP BRAIN STIMULATION (DBS) AT THE GLOBUS PALLIDUS PARS INTERNUS (GPI) IS AN EFFECTIVE TREATMENT FOR SOME PTS WITH MEDICALLY REFRACTORY TORSION DYSTONIA. IN THIS CHAPTER, WE REVIEW THE CLASSIFICATION AND TREATMENT OF TORSION DYSTONIA INCLUDING THE CURRENT INDICATIONS FOR DBS SURGERY. REPORTABLE EVENT: ONLY ONE PT WITH DYTI -ASSOCIATED DYSTONIA HAS REQUIRED LEAD REPOSITIONING DUE TO AN INADEQUATE RESPONSE. THE REPOSITIONING WAS PERFORMED SUCCESSFULLY AND HAS RESULTED IN A RAPID AND DRAMATIC IMPROVEMENT IN HIS CONTRALATERAL DYSTONIA. OTHER REFERENCE EVENTS WERE PREVIOUSLY REPORTED FROM OTHER ARTICLES PUBLISHED ON THE SAME PT COHORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=2| LEAD EXTENSION MODEL UNK N=2