BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1209878 · Received October 22, 2008

    Report

    Report Number
    2182207-2008-06762
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 4, FEMALE AT IMPLANT, HAD THREE EPISODES OF SUDDEN CLINICAL DETERIORATION DUE TO LEAD FRACTURES NECESSITATING REPEAT SURGERY.

    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 53 YR Required Intervention IPG ITREL II MODEL 7424 N=1| PROGRAMMER MODEL UNK N=2| EXTENSION MODEL UNK N=2| LEAD MODEL 3387 N=2