BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2246528 · Received September 6, 2011

    Report

    Report Number
    3007566237-2011-07436
    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: 10.1093/BRAIN/AWQ380. 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 THAT ONE PT (PT 2) EXPERIENCED A SERIOUS SMALL PARENCHYMAL HEMORRHAGE VENTRAL TO THE TIP OF THE ELECTRODE RESULTING IN VENTRICLE GAZE PALSY WITH NORMAL VERTICAL VESTIBULAR OCULAR REFLEXES, INDICATING A SUPRANUCLEAR DEFICIT. THIS RESOLVED AFTER 6 MONTHS AS SEEN ON OBJECTIVE OPHTHALMOLOGICAL MEASUREMENTS; HOWEVER, PERSISTENT SUBJECTIVE SLOWING OF VERTICAL FIXATION AND PURSUIT ON STIMULATION LED THE PT TO SWITCH OFF THE STIMULATOR AFTER COMPLETING THE CROSS-OVER PERIOD. STIMULATION ONCE A MONTH FOR A FEW HOURS DID NOT ADVERSELY AFFECT THE SUBJECTIVE COMPLAINT OF SLOWING BUT SEEMED TO PROLONG THE BENEFICIAL EFFECT ON TICS. IT WAS REPORTED THAT THERE WAS A SUBSTANTIAL BENEFICIAL EFFECT OF STIMULATION WAS OBSERVED IN THE UNBLINDED ASSESSMENT AT 1 YEAR AFTER SURGERY WHEN COMPARED WITH PREOPERATIVE ASSESSMENT. THE PT'S ELEVATED OBSESSIVE-COMPULSIVE BEHAVIOUR SHOWED IMPROVEMENT WHEN IN THE STIMULATION ON CONDITION.

    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 39 YR Other| S IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# UNK| LEAD: MODEL 3389, LOT# UNK