BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1943891 · Received December 28, 2010

    Report

    Report Number
    3007566237-2010-10797
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    August 27, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: LOBSIEN E, GRUBER D, SCHNEIDER GH, KUHN AA, KUPSCH A. LATROGENIC BELLY DANCER SYNDROME FOLLOWING QUADRUPLE DEEP BRAIN STIMULATION IN A PATIENT WITH MYOCLONUS DYSTONIA (DYT11). MOV DISORD. NOV 15 2010; 25(15): 2692-2693. SUMMARY: A (B)(6) FEMALE PATIENT HAD DEVELOPED SYMPTOMS OF MYOCLONUS AND DYSTONIA IN EARLY CHILDHOOD. WITH DISEASE PROGRESSION INTO HER TEENAGE YEARS DYSTONIC SYMPTOMS DEVELOPED INCLUDING CERVICAL DYSTONIA AND DYSTONIC POSTURING OF THE EXTREMITIES ESPECIALLY THE LEFT ARM LEASING TO SEVERE DISABILITY. THE AUTHORS PRESENT A CASE REPORT OF A RARE SURGICAL ADVERSE EVENT OF QUADRUPLE DBS IN A PATIENT WITH MYOCLONUS-DYSTONIA (MD) WHO RECEIVED BILATERAL VIM- AND EVALUATED FOR DBS IN 2005 AND WAS TREATED IN 2006. THE THERAPY WAS REPORTED TO BE EFFECTIVE. EVENT: THE AUTHORS REPORT THAT TWO YEARS AFTER SURGERY, DYSESTHESIAS AND PAIN IN THE REGION OF THE PULSE GENERATORS DEVELOPED. AT PRESENTATION "UP AND DOWN DANCING" OF THE PULSE GENERATORS RELATED TO HEAD ROTATION WAS NOTICED AND IDENTIFIED AS IATROGENIC HEAD-MOVEMENT-INDUCED BELLY DANCER SYNDROME. THESE MOVEMENTS OF THE STIMULATOR WERE PRESUMABLY CAUSED BY SHORTENING OF THE ELECTRODE LEADS DUE TO CONNECTIVE TISSUE TRANSFORMATION. SURGICAL REVISION WITH REPOSITIONING OF THE ELECTRODE LEADS AND LOOSENING OF TISSUE ADHESIONS SHOWED COMPLETE RELIEF OF THESE SYMPTOMS.

    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 30 YR Required Intervention