BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2246530 · Received September 6, 2011

    Report

    Report Number
    3007566237-2011-07439
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: ASKERMANS L, DUITS A, VAN DER LINDEN C, ET AL. DOUBLE-BLIND CLINICAL TRIAL OF THALAMIC STIMULATION IN PTS WITH TOURETTE SYNDROME. BRAIN. MAR 2011;134(PT3):832-844. DOI: (B)(6). SUMMARY: THE AUTHORS USED DEEP BRAIN STIMULATION OF THE THALAMUS AS A THERAPEUTIC OPTION IN PTS WITH TOURETTE SYNDROME WHO ARE REFRACTORY TO PHARMACOLOGICAL AND PHYSIOTHERAPEUTIC TREATMENT. PTS WERE INVITED TO TAKE PART IN A DOUBLE-BLIND RANDOMIZED CROSS-OVER TRIAL ASSESSING THE EFFICACY AND SAFETY OF STIMULATION OF THE CENTROMEDIAN NUCLEUS - SUBSTANTIA PERIVENTRICULARIS - NUCLEUS VENTRO-ORALIS INTERNUS CROSSPOINT IN THE THALAMUS FROM (B)(6) 2005 TO 2009. AFTER SURGERY, THE PTS WERE RANDOMLY ASSIGNED TO 3 MONTHS STIMULATION FOLLOWED BY 3 MONTHS OFF STIMULATION (GROUP A) OR VICE VERSA (GROUP B). THE CROSS-OVER PERIOD WAS FOLLOWED BY 6 MONTHS ON STIMULATION. ASSESSEMENTS WERE PERFORMED PRIOR TO SURGERY AND AT 3, 6 MONTHS AND 1 YEAR AFTER SURGERY. ALL PTS EXPERIENCED SUBJECTIVE GAZE DISTURBANCES AND REDUCTION OF ENERGY LEVELS; THERE WERE NO REPORTS OF ANY SEXUAL PROBLEMS. REPORTABLE EVENT: THE AUTHORS REPORTED ON A PT (PT 7) WHO WAS A (B)(6) INSTITUTIONALIZED FEMALE WITH VERY SERIOUS SELF-INJURIOUS BEHAVIOR AND LIFE THREATENING TICS. POSTOPERATIVELY, THIS PT DEVELOPED NEUROLOGICAL SYMPTOMS INCLUDING HYPERTONIA, MUTISM AND REPEATED FAINTING, WHICH NEEDED EXTENSIVE DIAGNOSTIC EVAL AND MULTIDISCIPLINARY TREATMENT. GIVEN THIS COMPLEX POSTOPERATIVE OUTCOME, SHE COULD NOT BE RANDOMIZED WITHIN THE PERIOD OF F/U AND THEREFORE WAS CONSIDERED AS LOST TO F/U. SEE ATTACHED LITERATURE ARTICLE WITH MFR REPORT # 3007566237-2011-07436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| O UNK 3389 LEADS (X2)