BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3554172 · Received January 6, 2014

    Report

    Report Number
    3007566237-2014-00044
    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 PRODUCTS: PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD. (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. 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 SELF LIMITING DISORDER REQUIRING NO FURTHER TREATMENT. REPORTED EVENT: ONE (B)(6) MALE PATIENT WITH PARKINSON'S DISEASE (PD) EXPERIENCED IRRITABILITY, CONFUSION, AND PRESERVATION FIVE DAYS AFTER DEEP BRAIN STIMULATION (DBS) IMPLANT SURGERY. THE REPORTER STATED THAT IMMEDIATELY POSTOPERATIVE CT REVEALED NO ABNORMALITIES SUCH AS HEMORRHAGE OR INFARCTION. THREE DAYS AFTER DBS IMPLANT, THE PATIENT¿S ANTI-PD MEDICATION WAS DISCONTINUED, THE DBS TURNED ON, AND THE STIMULATION PARAMETERS ADJUSTED. THE REPORTER STATED THAT THE PATIENT SHOWED A DRAMATIC IMPROVEMENT IN HIS PD-RELATED MOTOR AND SENSORY SYMPTOMS. REPORTEDLY, ON POSTOPERATIVE DAY (POD) 3, A ROUTINE BLOOD TEST SHOWED SLIGHTLY INCREASED ERYTHROCYTE SEDIMENTATION RATE (ESR) AND ELEVATED HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP), BUT THE PATIENT WAS AFEBRILE WITH A NORMAL WHITE BLOOD CELL (WBC) COUNT. ON POD 5, THE PATIENT REPORTEDLY SHOWED ABRUPT NEUROLOGICAL DETERIORATION, WITH SYMPTOMS OF FRONTAL LOBE DYSFUNCTION, SUCH AS CONFUSION, PERSEVERATION AND DISINHIBITION. THE REPORTER STATED THAT CT IMAGES THEN SHOWED BILATERAL, ROUND, LOW-DENSITY LESIONS IN THE WHITE MATTER ALONG THE DBS ELECTRODES. HOWEVER, THE PATIENT¿S HS-CRP HAD REPORTEDLY DECREASED SLIGHTLY, THE WBC COUNT WAS WITHIN NORMAL RANGE AND THE PATIENT REMAINED AFEBRILE. THE REPORTER STATED THAT ALTHOUGH THERE WAS NO EVIDENCE OF INFECTION, THE PATIENT WAS TREATED WITH EMPIRICAL ANTIBIOTIC THERAPY AS POSTOPERATIVE INFECTION COULD NOT BE COMPLETELY RULED OUT BASED ON ABNORMAL CT FINDINGS. THE PATIENT¿S MOTOR PERFORMANCE WAS REPORTEDLY EXCELLENT WITHOUT ANY ANTI-PD MEDICATION, BUT THE PATIENT¿S FRONTAL LOBE SYMPTOMS CONTINUED FOR SEVERAL DAYS. FROM POD 9, THE PATIENT¿S ABNORMAL BEHAVIOR REPORTEDLY DECREASED GRADUALLY AND HAD ALMOST RETURNED TO NORMAL ON POD 18. THE REPORTER STATED THAT THE LOW-ATTENUATION LESIONS ON THE CT IMAGES WERE MAINTAINED UNTIL POD 8, AND DECREASED GRADUALLY AFTER POD 18 AND HAD COMPLETELY DISAPPEARED BY POD 29. AN MRI ON POD 39 REPORTEDLY SHOWED NO ABNORMAL FINDINGS. 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. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5330 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention