BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5648458 · Received May 11, 2016

    Report

    Report Number
    3007566237-2016-01943
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    March 23, 2016
    Report Date
    May 11, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. 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

    COLEMAN, R.R., STARR, P.A., KATZ, M., GLASS, G.A., VOLZ, M., KHANDHAR, S.M., OSTREM, J.L. BILATERAL VENTRAL INTERMEDIATE NUCLEUS THALAMIC DEEP BRAIN STIMULATION IN ORTHOSTATIC TREMOR. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2016. 94:2(69-74). DOI: 10.1159/000444127 SUMMARY: ORTHOSTATIC TREMOR (OT) IS CHARACTERIZED BY HIGH-FREQUENCY LEG TREMOR WHEN STANDING STILL, RESULTING IN A SENSE OF IMBALANCE, WITH LIMITED TREATMENT OPTIONS. VENTRAL INTERMEDIATE (VIM) NUCLEUS THALAMIC DEEP BRAIN STIMULATION (DBS) HAS BEEN REPORTED AS BENEFICIAL IN A FEW CASES. REPORTED EVENTS: PATIENT 2: A (B)(6) FEMALE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE VENTRAL INTERMEDIATE (VIM) NUCLEUS OF THE THALAMUS TO TREAT ORTHOSTATIC TREMOR (OT) WAS HOSPITALIZED FOR 2 BRIEF GENERALIZED TONIC-CLONIC SEIZURES ON POSTOPERATIVE DAY 3 THAT WERE TRANSIENTLY TREATED WITH LOW DOSE LEVETIRACETAM WITHOUT RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301726 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R