BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1163555 · Received September 17, 2008

    Report

    Report Number
    2182207-2008-05846
    Event Type
    Injury
    Date Received
    September 17, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SHUURMAN PR, BOSCH DA, MERKUS MP, SPEELMAN JD. LONG-TERM FOLLOW-UP OF THALAMIC STIMULATION VERSUS THALAMOTOMY FOR TREMOR SUPPRESSION. MOV DISORD. 2008; 23(8): 1146-1153. THALAMIC STIMULATION AND THALAMOTOMY FOR TREATMENT OF TREMOR DUE TO PARKINSON'S DISEASE, ESSENTIAL TREMOR, AND MULTIPLE SCLEROSIS WERE COMPARED IN A RANDOMIZED TRIAL. THE SYMPTOMATIC AND FUNCTIONAL OUTCOME WAS STUDIED AFTER 5 YEARS OF FOLLOW-UP. SIXTY-EIGHT PATIENTS WERE TREATED (45 PD, 13 ET, 10 MS) BY THALAMOTOMY (N = 34) OR THALAMIC STIMULATION (N = 34). AFTER 5 YEARS, 48 PATIENTS WERE AVAILABLE FOR FOLLOW-UP. REPORTABLE EVENT: FIVE STIMULATION PATIENTS EXPERIENCED GAIT AND BALANCE DISTURBANCE. SEE MFG REPORT 2182207200805826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II MHY MEDTRONIC NEUROMODULATION 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LEAD MODEL 3387 N=1| EXTENSION MODEL UNK N=1| PROGRAMMER MODEL UNK N=1