BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3554178 · Received January 6, 2014

    Report

    Report Number
    3007566237-2014-00045
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    September 6, 2013
    Report Date
    December 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    KIM, J. W., HWANG, J. H., KIM, I. K., KIM, Y. E., YANG, H-J., EHM, G., KIM, H-J., KIM, D. G., PAEK, S. H., JEON, B. S. ACUTE BRAIN REACTION TO DBS ELECTRODES AFTER DEEP BRAIN STIMULATION: CHRONOLOGICAL OBSERVATION. ACTA NEUROCHIRURGICA. 2013;155(12):2365-2371. DOI 10.1007/S00701-013-1853-3. SUMMARY: BACKGROUND AS INCREASING NUMBERS OF DEEP BRAIN STIMULATION (DBS) PROCEDURES ARE PERFORMED, RARE ABNORMAL FINDINGS ON POSTOPERATIVE IMAGES THAT ARE NOT ATTRIBUTABLE TO WELL-KNOWN COMPLICATIONS ARE REPORTED. BETWEEN 2005 AND 2012, WE ENCOUNTERED SEVERAL SYMPTOMATIC PATIENTS WITH TRANSIENT ABNORMAL LOW-ATTENUATION LESIONS ON POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS. THE AIM OF THIS STUDY WAS TO CLARIFY THIS RARE PHENOMENON USING CHRONOLOGICAL OBSERVATIONS AND TO SUGGEST A FEASIBLE MECHANISM. IN THIS PERIOD, SEVEN (3.2 %) PATIENTS DISPLAYED TRANSIENT INCREASED LOW-ATTENUATION SIGNALS, CIRCUMFERENTIALLY SURROUNDING THE DBS ELECTRODES AND EXTENDING INTO THE SUBCORTICAL WHITE MATTER. ALL THESE PATIENTS SUFFERED FROM UNEXPECTED BUT TRANSIENT NEUROLOGICAL SYMPTOMS DURING THE POSTOPERATIVE PERIOD. THE ABNORMAL LOW-ATTENUATION LESIONS ONLY DISAPPEARED COMPLETELY A CONSIDERABLE TIME AFTER THE CLINICAL SYMPTOMS HAD DISAPPEARED, WITHOUT TREATMENT IN MOST PATIENTS. WE REPORT HERE OUR CHRONOLOGICAL OBSERVATIONS OF ACUTE BRAIN REACTIONS AFTER DBS PROCEDURES, WHICH WE BELIEVE ARE NEITHER INFECTIOUS NOR VASCULAR, BUT ARE POSSIBLY CAUSED BY THE MECHANICAL BREAKDOWN OF THE BLOOD¿BRAIN BARRIER BY MICROELECTRODE RECORDINGS OR BY ANCHORED DBS ELECTRODES. THESE LESIONS ARE THOUGHT TO CONSTITUTE A SELFLIMITING DISORDER REQUIRING NO FURTHER TREATMENT. REPORTED EVENT: ONE (B)(6) FEMALE PATIENT WITH PARKINSON'S DISEASE (PD) EXPERIENCED A SEIZURE 11 DAYS AFTER DEEP BRAIN STIMULATION (DBS) IMPLANT SURGERY. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY PRIOR SEIZURES. IT WAS NOTED THAT THE PATIENT HAD RECOVERED IMMEDIATELY AND FULLY AFTER THE DBS PROCEDURE WITH NO FOCAL NEUROLOGICAL DEFICIT. A CT IMAGE SHOWED BILATERAL LOW-ATTENUATION LESIONS AROUND THE ELECTRODES AND EXTENDING INTO THE SUBCORTICAL WHITE MATTER. IT WAS NOTED THAT THE CT IMAGE SHOWED NO EVIDENCE OF HEMORRHAGE, INFARCTION, OR INFECTION. THE REPORTER STATED THAT THE PATIENT WAS MANAGED WITH ONLY CLINICAL OBSERVATION, WITHOUT TREATMENT. THE PATIENT¿S SYMPTOMS PERSISTED FOR 1 DAY AND THE DURATION OF THE ABERRANT SIGNAL WAS 23 DAYS. THE REPORTER BELIEVED THAT THE ACUTE MECHANICAL BLOOD BRAIN BARRIER (BBB) BREAKDOWN RESULTING FROM THE BRAIN PARENCHYMAL DAMAGE DURING THE SURGERY ASSOCIATED WITH MICROELECTRODE RECORDINGS (MER) OR BY THE ANCHORED DBS ELECTRODES WAS A PLAUSIBLE EXPLANATION FOR THE ACUTE BRAIN REACTION OBSERVED ALONG THE WHITE MATTER TRACTS OF THE DBS ELECTRODES. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5352 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other