BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3874107 · Received June 16, 2014

    Report

    Report Number
    3007566237-2014-01657
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    LITERATURE AND FOREIGN BOTH SHOULD HAVE BEEN CHECKED ON THE INITIAL REPORT.

    Description of Event or Problem · 1

    SCHMITT, F. C., VOGES, J., HEINZE, H. J., ZAEHLE, T., HOLTKAMP, M., KOWSKI, A. B. SAFETY AND FEASIBILITY OF NUCLEUS ACCUMBENS STIMULATION IN FIVE PATIENTS WITH EPILEPSY. JOURNAL OF NEUROLOGY. 2014. DOI: 10.1007/S00415-014-7364-1 SUMMARY: IN FIVE ADULT PATIENTS WITH INTRACTABLE PARTIAL EPILEPSY, SAFETY AND FEASIBILITY OF CHRONIC BILATERAL ELECTRICAL STIMULATION OF THE NUCLEUS ACCUMBENS (NAC) WERE ASSESSED, ALSO PROVIDING INITIAL INDICATIONS OF THERAPEUTIC EFFICACY. CONCURRENT MEDICATION REMAINED UNCHANGED. IN THIS PHASE 1 TRIAL, CLINICAL OUTCOME PARAMETERS OF INTEREST WERE QUALITY OF LIFE IN EPILEPSY QUESTIONNAIRE (QOLIE-31-P), BECK DEPRESSION INVENTORY, MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW, NEUROPSYCHOLOGICAL TESTING, AND LIVERPOOL SEIZURE SEVERITY SCALE. THOSE DATA WERE OBTAINED AFTER 6 MONTHS OF NAC STIMULATION AND COMPARED TO THE EQUIVALENT ASSESSMENTS MADE DIRECTLY BEFORE IMPLANTATION OF ELECTRODES. ADDITIONALLY, MONTHLY FREQUENCIES OF SIMPLE PARTIAL SEIZURES, COMPLEX PARTIAL SEIZURES (CPS), AND GENERALISED TONIC¿CLONIC SEIZURES (GTCS) WERE ASSESSED DURING 3 MONTHS BEFORE ELECTRODE IMPLANTATION AND AT THE END OF 6-MONTH NAC STIMULATION. PROPORTION OF RESPONDERS, I.E. C50 % REDUCTION IN FREQUENCY OF DISABLING SEIZURES (SUM OF CPS AND GTCS), WAS CALCULATED. MAIN FINDINGS WERE UNCHANGED PSYCHIATRIC AND NEUROPSYCHOLOGICAL ASSESSMENT AND A SIGNIFICANT DECREASE IN SEIZURE SEVERITY (P = 0.043). QOLIE-31-P TOTAL SCORE TRENDED TOWARDS IMPROVEMENT (P = 0.068). TWO OUT OF FIVE PARTICIPANTS WERE RESPONDERS. THE MEDIAN REDUCTION IN FREQUENCY OF DISABLING SEIZURES WAS 37.5 %. IN SUMMARY,WE PROVIDE INITIAL EVIDENCE FOR SAFETY AND FEASIBILITY OF CHRONIC ELECTRICAL STIMULATION OF THE NACIN PATIENTS WITH INTRACTABLE PARTIAL EPILEPSY, AS INDICATED BY LARGELY UNCHANGED NEUROCOGNITIVE FUNCTION AND PSYCHIATRIC COMORBIDITY. EVEN THOUGH OUR DATA ARE UNDERPOWERED TO RELIABLY ASSESS EFFICACY, THE SIGNIFICANT DECREASE IN SEIZURE SEVERITY PROVIDES AN INITIAL INDICATION OF "ANTIICTAL" EFFICACY OF NAC STIMULATION. THIS CALLS FOR LARGER AND AT BEST RANDOMISED TRIALS TO FURTHER ELUCIDATE EFFICACY OF NAC STIMULATION IN PATIENTS WITH PHARMACOLOGICALLY INTRACTABLE EPILEPSY. REPORTED EVENT: A 53 YEAR OLD FEMALE DID NOT RESPOND TO STIMULATION OF THE NUCLEUS ACCUMBENS. THE PATIENT ALSO REPORTEDLY HAD AN INCREASE IN TOTAL NUMBER OF PSYCHIATRIC CONDITIONS FROM 0 TO 2; AND INCLUDED NEW ONSET GENERALIZED ANXIETY DISORDER AFTER 6 MONTHS AND MAJOR DEPRESSION. STIMULATION ALSO HAD TO BE TURNED DOWN IN THIS PATIENT DUE TO AN ABRUPT INCREASE IN SEIZURE FREQUENCY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352576 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601 UNKNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention