BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 19095347 · Received April 12, 2024

    Report

    Report Number
    2182207-2024-02284
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    November 1, 2005
    Report Date
    April 12, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G2 CITATION: CASTELA M. D., FERNANDEZ P. P., BRUCK S. H., MARTIN E. S. S., FERNANDEZ C. G., ALVAREZ J. S., ARAGONESES B. L., AYALA A. S., LIEBANA E. S., CARRILES J. A., ALVAREZ L. G., ESTRADA M. B. PARKINSONISM-HYPERPYREXIA, A RARE CONSEQUENCE OF DEEP BRAIN STIMULATOR MALFUNCTION IN ADVANCED PARKINSON¿S DISEASE CLINICAL PARKINSONISM AND RELATED DISORDERS 10 2024 DOI: 10.1016/J.PRODOA.2024.100246 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CASTELA M. D., FERNANDEZ P. P., BRUCK S. H., MARTIN E. S. S., FERNANDEZ C. G., ALVAREZ J. S., ARAGONESES B. L., AYALA A. S., LIEBANA E. S., CARRILES J. A., ALVAREZ L. G., ESTRADA M. B. PARKINSONISM-HYPERPYREXIA, A RARE CONSEQUENCE OF DEEP BRAIN STIMULATOR MALFUNCTION IN ADVANCED PARKINSON¿S DISEASE CLINICAL PARKINSONISM AND RELATED DISORDERS 10 2024 DOI: 10.1016/J.PRODOA.2024.100246. ABSTRACT: PARKINSONISM-HYPERPYREXIA SYNDROME (PHS) IS A RARE NEUROLOGICAL EMERGENCY THAT SHARES CLINICAL FEATURES WITH NEUROLEPTIC MALIGNANT SYNDROME. IT IS USUALLY DUE TO SUDDEN DEPRIVATION OF DOPAMINERGIC TREATMENT, ALTHOUGH THERE ARE CASES RELATED TO FAILURE OF THE DEEP BRAIN STIMULATION SYSTEM. REPORTED EVENTS: 1) A 73-YEAR-OLD MAN WAS DIAGNOSED WITH ADVANCED-STAGE PD WITH A NST IMPLANT USING THE KINETRA SYSTEM IN NOVEMBER 2005. HE WAS ADMITTED DUE TO SUBACUTE WORSENING OF BODY STIFFNESS, MARKED BRADYKINESIA, INABILITY TO SWALLOW LEVODOPA TABLETS, A HIGH TEMPERATURE OF UP TO 38.9 DEGREES CELSIUS, AND PROFUSE RESPIRATORY SECRETIONS. DUE TO LACK OF RESPONSE TO ANTIBIOTIC TREATMENT, NORMAL BRAIN IMAGING TESTS, NORMAL CEREBROSPINAL FLUID ANALYSIS, AND OBSERVATION OF A DISCHARGE ON THE NEUROSTIMULATOR BATTERY, PHS SYNDROME WAS CONSIDERED. DESPITE INCREASES IN THE DOSE OF DOPAMINERGIC THERAPY, THE PATIENT EXPERIENCED RESPIRATORY DETERIORATION, DYSAUTONMIC SYMPTOMS AND RENAL FAILURE DUE TO AN INCREASE IN CK (FROM 530U/L TO 7500 U/L OVER 7 DAYS), REQUIRING TRANSFER TO THE ICU. AFTER STABILIZATION, THE NEURO STIMULATOR WAS REPLACED WITH THE LIBRA XP MODEL (ABBOTT) WITHOUT INITIAL COMPLICATIONS. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808887 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization