BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1329181 · Received February 25, 2009

    Report

    Report Number
    2182207-2009-01298
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    December 31, 2007
    Report Date
    January 14, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: ZIBETTI M, PESARE M, CINQUEPALMI A, ET AL. ANTIPARKINSONIAN THERAPY MODIFICATIONS IN PD PATIENTS AFTER STN DBS: A RETROSPECTIVE OBSERVATIONAL ANALYSIS. PARKINSONISM RELAT DISORD. 2008; 14(8): 608-612. LITERATURE SUMMARY: DESCRIPTION OF THE MODIFICATIONS OF ALL ANTIPARKINSONIAN TREATMENTS, INCLUDING LEVODOPA, DOPAMINE AGONISTS AND ASSOCIATED ANTIPARKINSONIAN DRUGS SUCH AS COMT AND MAO INHIBITORS, AMANTADINE AND ANTICHOLINERGICS, IN A GROUP OF 67 CONSECUTIVE PD PATIENTS SURGICALLY TREATED BY STN DBS WITH AN ASSESSMENT UP TO 3 YEARS. PATIENT 3 OF 5 HAD DEEP VEIN THROMBOSIS REPORTED TO BE DIRECTLY RELATED TO THE PROCEDURE. SEE MANUFACTURER REPORT NUMBER: 2182207200901296.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL LEADMVD| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTESNION MVD| EXPLANTED: