BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5945918 · Received September 13, 2016

    Report

    Report Number
    3007566237-2016-03210
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    April 26, 2016
    Report Date
    September 13, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TAMAS, G., KOVACS, N., VARGA, N.A., BARSI, P., EROSS, L., MOLNAR, M.J., BALAS, I. DEEP BRAIN STIMULATION OR THALAMOTOMY IN FRAGILE X-ASSOCIATED TREMOR/ATAXIA SYNDROME? CASE REPORT. NEUROLOGIA I NEUROCHIRURGIA POLSKA. 2016. 50(4):303-308. DOI: 10.1016/J.PJNNS.2016.04.004 SUMMARY/ REPORTED EVENTS: ONE (B)(6) MALE PATIENT WITH ESSENTIAL TREMOR (ET) WAS REFERRED TO PREOPERATIVE EVALUATION FOR DEEP BRAIN STIMULATION (DBS) IN 2010. HIS HAND TREMOR HAD STARTED AT THE AGE OF (B)(6)AND WAS CHARACTERIZED BY A KINETIC INTENTION TREMOR WITH RIGHT-SIDED PREDOMINANCE; HE COMPLAINED OF SLIGHT INSTABILITY WHICH STARTED AT THE AGE OF (B)(6). TREATMENT OF HYPERTENSION AND TYPE 2 DIABETES MELLITUS WAS ALSO REPORTED IN HIS MEDICAL HISTORY. AT THE AGE OF (B)(6), BILATERAL SUBTHALAMIC NUCLEUS (STN) DBS ELECTRODES WERE IMPLANTED. NEUROPHYSIOLOGICAL TARGET WAS VERIFIED VIA MICROELECTRODE RECORDING AND MACROSTIMULATION INTRA-OPERATIVELY BEFORE LEAD INSERTION. ALTHOUGH TREMOR WAS SUPPRESSED SUBSTANTIALLY INTRA-OPERATIVELY, IT WAS MODERATELY DECREASED FOR ONLY THREE MONTHS POST-OPERATIVELY. IN THE MEANTIME, THE PATIENT'S GAIT ATAXIA AND POSTURAL INSTABILITY PROGRESSED TO AN EXTENT THAT HE BECAME DEPENDENT ON A WALKING AID. GAZE-DIRECTED NYSTAGMUS, SLIGHT DYSARTHRIA, SYMMETRIC POSTURAL TREMOR, KINETIC AND ESPECIALLY INTENTION TREMOR WITH RIGHT-SIDED PREPONDERANCE WERE OBSERVED. HE COMPLAINED OF URINARY INCONTINENCE; MODERATE CARDIOVASCULAR AUTONOMIC NEUROPATHY WAS ALSO DETECTED, WHILE HIS COGNITIVE STATUS REMAINED UNCHANGED. HIS IMMOBILITY PROGRESSED FURTHER AFTER 10 MONTHS, FIRST WITH THE NEED OF A WALKER UNTIL HE BECAME WHEELCHAIR BOUND. HIS SPEECH TURNED INTO "SCANNING." IMPEDANCE MEASUREMENT SUGGESTED A BREAKAGE OF THE LEFT DBS LEAD, THUS "CONTROL" MRI EXAMINATION WAS PERFORMED. GLOBAL BRAIN ATROPHY AND A MORE PRONOUNCED SYMMETRICAL, BILATERAL T2 HYPERINTENSITY IN THE MIDDLE CEREBELLAR PEDUNCLES (MCP) WERE OBSERVED. GENETIC TESTING THEN REVEALED 95 CGG TRINUCLEOTIDE REPEAT IN THE FMR1 GENE, SUPPORTING THE DIAGNOSIS OF FRAGILE X-ASSOCIATED TREMOR/ATAXIA SYNDROME. DESPITE THE STN STIMULATION, THE TREMOR CONSIDERABLY WORSENED WITH TIME TO AN EXTENT THAT THE PATIENT WAS NOT ABLE TO PERFORM ORDINARY DAILY ACTIVITIES. AT THE PATIENT'S REQUEST, AN ADDITIONAL OPERATION WAS PLANNED; AN MRI-GUIDED STEREOTACTIC THALAMOTOMY ON THE LEFT SIDE AS A LAST RESORT SURGICAL OPTION. BOTH STN LEADS WERE REMOVED PRIOR TO THIS OPERATION. LESIONING IMPROVED THE POSTURAL TREMOR OF THE PROXIMAL AND DISTAL ARM, WHILE A MILD KINETIC TREMOR REMAINED; THE EFFECT WAS UNCHANGED AFTER A SIX-MONTH OBSERVATION PERIOD. THE AUTHOR STATED THAT THE WORSENING OF ATAXIA FOLLOWING DBS IMPLANT COULD BE CORRELATED WITH THE DELAYED EXPANSE OF BILATERAL MCP SIGNS. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED IN THE ARTICLE: LEAD MODEL 3389 AND IMPLANTABLE NEUROSTIMULATOR ACTIVA PC MODEL 37601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599513 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention