BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6853558 · Received September 8, 2017

    Report

    Report Number
    3007566237-2017-03756
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    January 1, 2013
    Report Date
    September 8, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE AND ITS ACCOMPANYING SUPPLEMENTAL MATERIAL: OLIVERIA SF, RODRIGUEZ RL, BOWERS D, KANTOR D, HILLIARD JD, MONARI EH, SCOTT BM, OKUN MS, FOOTE KD. SAFETY AND EFFICACY OF DUAL-LEAD THALAMIC DEEP BRAIN STIMULATION FOR PATIENTS WITH TREATMENT-REFRACTORY MULTIPLE SCLEROSIS TREMOR: A SINGLE-CENTRE, RANDOMIZED, SINGLE-BLIND, PILOT TRIAL. LANCET NEUROLOGY (2017) DOI: 10.1016/S1474-4422(17)30166-7 SUMMARY: EFFICACY IN PREVIOUS STUDIES OF SURGICAL TREATMENTS OF REFRACTORY MULTIPLE SCLEROSIS TREMOR USING LESIONING OR DEEP BRAIN STIMULATION (DBS) HAS BEEN VARIABLE. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF DUAL-LEAD THALAMIC DBS (ONE TARGETING THE VENTRALIS INTERMEDIUS-VENTRALIS ORALIS POSTERIOR NUCLEUS BORDER [THE VIM LEAD] AND ONE TARGETING THE VENTRALIS ORALIS ANTERIOR-VENTRALIS ORALIS POSTERIOR BORDER [THE VO LEAD]) FOR THE TREATMENT OF MULTIPLE SCLEROSIS TREMOR. D.2. AND G.5. PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS THERE WERE TWO LEADS IMPLANTED IN THE SAME HEMISPHERE FOR TREATMENT OF MULTIPLE SCLEROSIS TREMOR. 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.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED IN A LITERATURE ARTICLE: REPORTED EVENT: (B)(6) AT TIME OF IMPLANT) WITH DUAL-LEAD THALAMIC DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF MULTIPLE SCLEROSIS TREMOR EXPERIENCED A NON-SERIOUS FRACTURE OF THE RIGHT FOOT FROM 01-JAN-2013 TO 01-MAY-2013. THE RELATEDNESS OF THIS WITH THE STUDY PROCEDURE COULD NOT BE DETERMINED. THE PATIENT ¿HEALED UP¿ AND WAS WEARING A ¿AKTO¿ WHICH WAS MADE FOR HER BY ORTHOTICS; SHE HAD BEEN WEARING IT SINCE (B)(6) 2013 AND HER FOOT FELT MUCH BETTER. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632169 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other