BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2480639 · Received March 6, 2012

    Report

    Report Number
    3007566237-2012-00482
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    August 19, 2011
    Report Date
    February 21, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    LITERATURE: MOTOR IMPROVEMENT WITH BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN A PATIENT WITH LEVODOPA-RESPONSIVE SECONDARY PARKINSONISM. VIKAS KOTAGALA,*, PARAG G. PATILB, KELVIN L. CHOUC. PARKINSONISM AND RELATED DISORDERS 18 (2012) 79-81. DOI:10. 1016/J.PARKRELDIS.2011.08.014. ABSTRACT: AT MANY CENTERS, SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IS NOT CONSIDERED FOR PATIENTS WITH SECONDARY FORMS OF PARKINSONISM, DUE TO HIGHER EXPECTED RATES OF TREATMENT FAILURE. WE PRESENT THE CASE OF A WOMAN WITH SECONDARY PARKINSONISM THAT DEVELOPED FOLLOWING A MEASLES, MUMPS, AND RUBELLA (MMR) VACCINATION, WHO EXPERIENCED SUSTAINED IMPROVEMENT IN MOTOR FUNCTION FOLLOWING STN DBS. DESPITE THE DIAGNOSIS OF A SECONDARY PARKINSONISM, THIS PATIENT RESPONDED WELL TO DOPAMINERGIC THERAPY, A GOOD PREDICTOR OF DBS OUTCOME IN PATIENTS WITH IDIOPATHIC PARKINSON'S DISEASE. THIS CASE SUGGESTS THAT DBS MAY BE CONSIDERED IN THE SETTING OF SECONDARY PARKINSONISM IF SUCH PATIENTS HAVE LEVODOPA RESPONSIVE SYMPTOMS. REPORTED EVENT: THE PATIENT UNDERWENT BILATERAL STN DBS ELECTRODE PLACEMENT FOLLOWED A MONTH LATER BY IMPLANTATION OF A KINETRA STIMULATOR (B)(4). POSTOPERATIVELY, SHE HAD A WOUND INFECTION REQUIRING IV ANTIBIOTICS BUT HAD NO TREMOR OR WEARING-OFF SYMPTOMS ONCE STIMULATION PARAMETERS WERE OPTIMIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention