BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5036102 · Received August 27, 2015

    Report

    Report Number
    3007566237-2015-02406
    Event Type
    Injury
    Date Received
    August 27, 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

    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. CONCOMITANT PRODUCT: PRODUCT ID 3389-40, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    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 SEIZURES UNDERWENT 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) FEMALE COMPLEX PARTIAL EPILEPSY PATIENT EXPERIENCED A "WORSENING OF SHORT-TERM VISUOSPATIAL MEMORY" WHEN GIVEN A NEUROPSYCHOLOGICAL EVALUATION. THIS CHANGE WAS NOTED WHEN COMPARING THE PATIENT'S ONE AND TWO YEAR POSTOPERATIVE FOLLOW-UPS. IT WAS ALSO REPORTED THAT AT THE TWO YEAR FOLLOW-UP THE PATIENT EXPERIENCED "A POSSIBLE WORSENING" THAT WAS "DUE TO HEADACHE AND PROLONGED MENTAL CONFUSION AFTER COMPLEX PARTIAL SEIZURE EPISODES." THE PATIENT OTHERWISE EXHIBITED AN "IMPROVEMENT IN EXECUTIVE TASKS AND PRACTICAL ABILITY AS WELL AS IN RATIONAL BEHAVIOR AND COMMUNICATIVE ABILITY. IT WAS NOTED THAT WHEN COMPARING THE PATIENT'S BASELINE AND TWO YEAR FOLLOW-UP, THE PATIENT EXPERIENCED AN INCREASE IN "IQ, ATTENTION, SHORT- AND LONG-TERM VISUAL SPATIAL MEMORY AND QUALITY OF LIFE IN EPILEPSY" SCORE. 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
    569152 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Other