BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1209873 · Received October 22, 2008

    Report

    Report Number
    2182207-2008-06764
    Event Type
    Injury
    Date Received
    October 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LOHER TJ, CAPELLE HH, KAELIN-LANG A, ET AL. DEEP BRAIN STIMULATION FOR DYSTONIA: OUTCOME AT LONG-TERM FOLLOW-UP. J NEUROL. 2008;255(6):881-884. DEEP BRAIN STIMULATION (DBS) HAS EMERGED AS A USEFUL THERAPEUTIC OPTION FOR PTS WITH INSUFFICIENT BENEFIT FROM CONSERVATIVE TREATMENT. NINE PTS HAD UNDERGONE PALLIDAL STIMULATION EXCEPT ONE PT WITH PAROXYSMAL DYSTONIA WHO UNDERWENT THALAMIC STIMULATION. DBS MAINTAINS MARKED LONG-TERM SYMPTOMATIC AND FUNCTIONAL IMPROVEMENT IN THE MAJORITY OF PTS WITH DYSTONIA. REPORTABLE EVENT: PT 7, A MALE AT IMPLANT OF UNILATERAL VIM DBS, RESULTED IN A MARKED DECREASE OF FREQUENCY, DURATION, AND INTENSITY OF THE PAROXYSMAL DYSTONIC ATTACKS. AFTER NINE YEARS OF CHRONIC THALAMIC STIMULATION, THERE WAS AN INCREASE OF THE FREQUENCY OF THE ATTACKS FROM 3 TIMES PER WEEK TO ABOUT 10 PER WEEK. IT WAS DECIDED THEN TO CHANGE TO PALLIDAL STIMULATION. THEREAFTER, THERE WAS A DECREASE OF THE FREQUENCY OF DYSTONIC ATTACKS. SEE MFG REPORT #2182207200806762.

    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 42 YR Required Intervention PROGRAMMER MODEL UNK N=1| LEAD MODEL 3387 N=1| EXTENSION MODEL UNK N=1