BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5980565 · Received September 27, 2016

    Report

    Report Number
    3007566237-2016-03385
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    January 1, 2007
    Report Date
    September 27, 2016
    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

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE YEAR THE PATIENT WAS FIRST IMPLANTED ACCORDING THE LITERATURE ARTICLE; THE SPECIFIC EVENT DATE WAS NOT PROVIDED. COMMON DEVICE NAME. AND PMA#. PLEASE NOTE THAT THE DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED TO TREAT EPILEPSY. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2007, 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

    SON, B.C., SHON, Y.M., CHOI, J.G., KIM, J., HA, S., KIM, S-H., LEE, S. CLINICAL OUTCOME OF PATIENTS WITH DEEP BRAIN STIMULATION OF THE CENTROMEDIAN THALAMIC NUCLEUS FOR REFRACTORY EPILEPSY AND LOCATION OF THE ACTIVE CONTACTS. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2016. 94(3):187-197. DOI: 10.1159/000446611 SUMMARY: TO INVESTIGATE THE CLINICAL OUTCOME OF PATIENTS TREATED WITH CHRONIC DEEP BRAIN STIMULATION (DBS) OF THE CENTROMEDIAN NUCLEUS (CM) FOR REFRACTORY EPILEPSY AND TO DETERMINE THE LOCATION OF ACTIVE CONTACTS. REPORTED EVENTS: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR NUCLEUS (ANT) DEEP BRAIN STIMULATION (DBS) FOR REFRACTORY EPILEPSY IN 2007. THE PATIENT SHOWED A PROMINENT SEIZURE REDUCTION TO A SEIZURE-FREE STATUS FOR THE MECHANICAL LESION EFFECT FOR 2 OR 3 MONTHS AFTER THE INITIAL IMPLANTATION; HE EXPERIENCED A REDUCTION IN SEIZURES OF 50% AT ONE YEAR. HOWEVER, THE ANTIEPILEPTIC EFFICACY WAS NOT MAINTAINED DURING THE PERIOD OF CHRONIC STIMULATION. APPROXIMATELY 7 YEARS AFTER IMPLANT, THE PATIENT UNDERWENT A REVISION TO MOVE BOTH LEADS TO THE CENTROMEDIAN THALAMIC NUCLEUS (CM) DUE TO A LOSS OF EFFICACY AND A MISPLACED LEAD ON THE RIGHT SIDE. NO SPECIFIC DEVICE INFORMATION REGARDING THIS EVENT WAS PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631661 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention