BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

    MDR report key: 6020949 · Received October 12, 2016

    Report

    Report Number
    3007566237-2016-03538
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    August 10, 2016
    Report Date
    October 12, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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. THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BEN-HAIM, S., FLATOW, V., CHEUNG, T., CHO, C., TAGLIATI, M., ALTERMAN, R.L. DEEP BRAIN STIMULATION FOR STATUS DYSTONICUS: A CASE SERIES AND REVIEW OF THE LITERATURE. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2016. 94(4):207-215. DOI: 10.1159/000446191 SUMMARY: WE PRESENT OUR EXPERIENCE WITH PALLIDAL DEEP BRAIN STIMULATION (DBS) IN 5 DYT1-POSITIVE PATIENTS WITH STATUS DYSTONICUS (SD) AND PROVIDE A REVIEW OF THE LITERATURE TO EXAMINE OPTIMAL MANAGEMENT. REPORTED EVENTS: ONE (B)(6) FEMALE PATIENT UNDERWENT BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) IMPLANT FOR TREATMENT OF DYSTONIA. APPROXIMATELY FOUR YEARS LATER, AT THE (B)(6), HER STIMULATORS WERE REPLACED DUE TO BILATERAL LEAD FRACTURES. THE AUTHORS REPORTED THAT THE PATIENTS WERE IMPLANTED WITH EITHER A 7426 SOLETRA, 37602/37603 ACTIVA SC, OR 37612 ACTIVA RC NEUROSTIMULATORS, AND MODEL 3387 LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION (SUCH AS SERIAL NUMBERS) FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674982 IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention