BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6260395 · Received January 18, 2017

    Report

    Report Number
    3007566237-2017-00175
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 18, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. 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

    OSTREM JL, SAN LUCIANO M, DODENHOFF KA, ZIMAN N, MARKUN LC, RACINE CA, DE HEMPTINNE C, VOLZ MM, HEATH SL, STARR PA. SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN ISOLATED DYSTONIA: A 3-YEAR FOLLOW-UP STUDY. NEUROLOGY 2017; 88:1-11 SUMMARY: THE OBJECTIVE OF THIS STUDY WAS TO REPORT LONG-TERM SAFETY AND EFFICACY OUTCOMES OF A LARGE COHORT OF PATIENTS WITH MEDICALLY REFRACTORY ISOLATED DYSTONIA TREATED WITH SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS). 1 FEMALE PATIENT WITH STN DBS FOR DYSTONIA DEVELOPED DYSPHORIA WHEN THE LEFT STN LEAD WAS ACTIVATED. THIS WAS CONSIDERED A SERIOUS ADVERSE EVENT AND OCCURRED WITHIN 12 MONTHS OF IMPLANT. DESPITE REPEATED ATTEMPTS AT REPROGRAMMING THE LEAD, A TOLERABLE SETTING WAS NOT FOUND. THE LEFT LEAD WAS EVENTUALLY TURNED OFF AND SHE STILL EXPERIENCED BENEFIT FROM UNILATERAL STIMULATION. POSTOPERATIVE IMAGING REVEALED SYMMETRICALLY PLACED LEADS. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389; IMPLANTABLE NEUROSTIMULATOR KINETRA; IMPLANTABLE NEUROSTIMULATOR ACTIVA PC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45647 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other