BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 5980782 · Received September 27, 2016

    Report

    Report Number
    3007566237-2016-03389
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    July 20, 2016
    Report Date
    October 9, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    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 DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. COMMON DEVICE NAME. AND REPORT SOURCE. PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR EPILEPSY. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389, PRODUCT TYPE: LEAD. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS EVENT TYPE WAS AN "ADVERSE EVENT AND PRODUCT PROBLEM". 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) FEMALE PATIENT WITH BILATERAL CENTROMEDIAN THALAMIC NUCLEUS (CM) DEEP BRAIN STIMULATION (DBS) FOR REFRACTORY EPILEPSY HAD MISPLACEMENT OF THE BILATERAL DBS LEADS DUE TO INTRAOPERATIVE BRAIN SHIFT. THIS NECESSITATED REPLACEMENT. THE PATIENT WENT ON TO HAVE A 60% REDUCTION IN SEIZURE FREQUENCY. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED IN THE ARTICLE: LEAD MODEL 3389 AND IMPLANTABLE NEUROSTIMULATOR MODEL 7426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630949 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention