BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5033026 · Received August 26, 2015

    Report

    Report Number
    3007566237-2015-02384
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    March 1, 2007
    Report Date
    July 28, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389-40, LOT# UNKNOWN; PRODUCT TYPE LEAD. (B)(4). PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS.

    Description of Event or Problem · 1

    PIACENTINO, M., DURISOTTI, C., GAROFALO, P.G., BONANNI, P., VOLZONE, A., RANZATO, F., BEGGIO, G. ANTERIOR THALAMIC NUCLEUS DEEP BRAIN STIMULATION (DBS) FOR DRUG-RESISTANT COMPLEX PARTIAL SEIZURES (CPS) WITH OR WITHOUT GENERALIZATION: LONG-TERM EVALUATION AND PREDICTIVE OUTCOME. ACTA NEUROCHIRURGICA. 2015. DOI 10.1007/S00701-015-2498-1 SUMMARY: DRUG-RESISTANT EPILEPTIC PATIENTS ACCOUNT FOR 40 % OF CASES OF EPILEPSY. CONSEQUENTLY, SPECIFIC THERAPEUTIC OPTIONS COULD BE SURGICAL RESECTION OR, IF NOT INDICATED, DEEP BRAIN STIMULATION (DBS). THE AIM OF THIS STUDY IS TO REVIEW DATA FROM PATIENTS AFFECTED BY DRUG-RESISTANT COMPLEX PARTIAL EPILEPSY WITH OR WITHOUT GENERALIZATION TREATED BY ANTERIOR THALAMIC NUCLEUS (AN) DBS TO EVALUATE THE EFFICACY AND POTENTIAL FUTURE APPLICATIONS OF THIS APPROACH AS A STANDARD METHOD FOR PALLIATIVE SEIZURE CONTROL. SIX PATIENTS AFFECTED BY DRUG-RESISTANT COMPLEX PARTIAL SEIZURESUNDERWENT AN DBS FROM MARCH 2007 TO FEBRUARY 2011. THE PREOPERATIVE TESTS CONSISTED OF ELECTROENCEPHALOGRAPHY (EEG), VIDEO EEG, MORPHOLOGIC AND FUNCTIONAL MAGNETIC RESONANCE IMAGING (MRI), NON-ACUTE POSITRON EMISSION TOMOGRAPHY (PET), NEUROPSYCHOLOGICAL EVALUATION, LIVERPOOL SEIZURE SCALE, AND QUALITY OF LIFE IN EPILEPSY (QOLIE). THESE TESTS AND A SEIZURE DIARY WERE ALSO ADMINISTERED DURING A FOLLOW-UP OF AT LEAST 3 YEARS. THE IMPROVEMENT IN TERMS OF DECREASE OF SEIZURES WAS MORE THAN 50 % IN PATIENTS AFFECTED BY COMPLEX PARTIAL SEIZURES STRICTLY RELATED TO LIMBIC SYSTEM ORIGIN. THE AMELIORATION WAS UNSATISFACTORY FOR PATIENTS HAVING ANATOMICAL LESIONS OUTSIDE THE LIMBIC STRUCTURES WITH EVIDENCE OF LATE DIFFUSION IN LIMBIC AREAS. ONE PATIENT DIED 40 DAYS AFTER SURGERY FOR REASONS NOT CONCERNED WITH DBS. ALTHOUGH THE LIMITED NUMBER OF ENROLLED PATIENTS LIMITS THE RELIABILITY OF DATA, THE RESULTS ARE IN ACCORDANCE WITH THOSE FOUND IN THE RECENT LITERATURE AND DESERVE TO BE CONSIDERED FOR FURTHER STUDIES REGARDING REAL EFFICACY, INDICATIONS, STIMULATION PARAMETERS, SIDE EFFECTS, AND COMPLICATIONS. REPORTED EVENTS: THE (B)(6) MALE COMPLEX PARTIAL EPILEPSY PATIENT EXPERIENCED NO CLEAR IMPROVEMENT IN THE FREQUENCY OF COMPLEX PARTIAL SEIZURES WHEN FOLLOWED-UP WITH 12 MONTHS AFTER SURGERY, THOUGH IT WAS NOTED THE EPISODES WERE SHORTER WITH RAPID RESOLUTION AND THE PATIENT HAD A 100% REDUCTION IN GENERALIZED SEIZURES WITH 0 AT THAT TIME. TWO YEARS AFTER IMPLANT THE PATIENT REMAINED THE SAME. IT WAS NOTED, THE PATIENT HAD EXPERIENCED EPILEPSY SYMPTOMS SINCE HE WAS (B)(6), WITH SYMPTOMS OF STARING, BLINKING, AND HEAD AND BODY ROTATION ON THE RIGHT SIDE. THEN DURING THE FOLLOWING YEAR, THE SITUATION REMAINED THE SAME, BUT AT 28 MONTHS THERE WERE TWO NEW EPISODES IN WHICH THE PATIENT SHOWED DIFFERENT INITIAL AUTOMATISMS WITH EXTENSION OF BOTH ARMS INSTEAD OF THE USUAL RIGHT HEAD AND TRUNK TORSION, BEFORE GENERALIZATION AND FALLS. AT THIS TIME THERAPY WAS CHANGED (MORE THAN 2 YEARS AFTER SURGERY) IN THE FOLLOWING MANNER: FELBAMATE AND ZONISAMIDE WERE REMOVED, LACOSAMIDE 450 MG/DAY WAS STARTED, AND CARBAMAZEPINE WAS INCREASED UP TO 1800 MG/DAY. THERE WAS NO CHANGE IN COMPLEX PARTIAL SEIZURES AND NO ELECTRO-ENCEPHALOGRAPHY (EEG) CHANGES WERE RECORDED DURING ALL THE POSTOPERATIVE PERIOD. THIS SYMPTOMATOLOGY WAS CONTROLLED BY THE INTRODUCTION OF BENZODIAZEPINE (20 MG/DAY) LEADING THE CLINICAL SITUATION TO THE PREVIOUS STABLE STATE DESCRIBED AT THE 2-YEAR FOLLOW-UP FROM SURGERY. A MONTH AFTER THE INTRODUCTION OF BENZODIAZEPINE, HE HAD NEW COMPLEX PARTIAL SEIZURES WITH NEW SYMPTOMS (NO TRUNK ROTATION, ARMS EXTENSION, AND STARING) CHARACTERIZED BY A MINUTE DURATION ON AVERAGE. THE BATTERY WAS TESTED AND REPLACED, ALTHOUGH THERE WAS STILL A CHARGE VALUE HIGHER THAN 20%, RESTORING THE CLINICAL SITUATION TO THAT REPORTED AT 2-YEAR FOLLOW-UP FROM SURGERY. THOUGH IT WAS NOTED, THE PATIENT PRESENTED A POSTOPERATIVE CONSTANT IMPROVEMENT LASTING MORE THAN TWO YEARS WITH A REDUCTION IN BOTH PARTIAL AND COMPLEX PARTIAL SEIZURES WITH GENERALIZATION AND FALLING EPISODES THE PATIENT THEN EXPERIENCED A PERIOD OF WORSENING THAT WAS CHARACTERIZED BY INCREASED SEIZURE FREQUENCY (17% FOR PARTIAL AND 75% FOR GENERALIZED SEIZURES) ASSOCIATED WITH CHANGED CLINICAL MANIFESTATIONS. THE PATIENT'S SEIZURE CONTROL BETWEEN MONTHS 28 TO 31 HAD PRESENTED, WITH THE ONSET OF ONE EPISODE PER MONTH OF PARTIAL SEIZURE FOLLOWED BY GENERALIZATION AND WITH THE CLINICAL MANIFESTATIONS OF COMPLEX PARTIAL SEIZURES CHANGED AS WELL WITH NEW AUTOMATISM CHARACTERIZED BY EXTENSION OF BOTH ARMS. THE PATIENT'S INS WAS REPLACED AS A RESULT AND THE PREVIOUS CLINICAL STATE WAS RESTORED IMMEDIATELY. IT WAS NOTED THE PATIENT DID NOT PERCEIVE THE AMELIORATION IN HIS QUALITY OF LIFE EVEN IF THE NEUROPSYCHOLOGICAL EVALUATION SHOWED BETTER SCORES IN MANY MENTAL ACTIVITIES (GLOBAL INTELLECTIVE IMPROVEMENT ATTENTION, SHORT-TERM MEMORY, AND IQ) AND THE LIVERPOOL DATA WERE IN ACCORDANCE WITH THE POSITIVE PROGRESSIVE SEIZURE CONTROL. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564535 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention