BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5979626 · Received September 27, 2016

    Report

    Report Number
    3007566237-2016-03377
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    March 8, 2016
    Report Date
    September 27, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION 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.

    Description of Event or Problem · 1

    SILVA, D., MATIAS, C., BOURNE, S., NAGEL, S., MACHADO, A., LOBEL, D. EFFECTS OF CHRONIC ALCOHOL CONSUMPTION ON LONG-TERM OUTCOMES OF THALAMIC DEEP BRAIN STIMULATION FOR ESSENTIAL TREMOR. JOURNAL OF CLINICAL NEUROSCIENCE : OFFICIAL JOURNAL OF THE NEUROSURGICAL SOCIETY OF AUSTRALASIA. 2016. 31:142-146. DOI: 10.1016/J.JOCN.2016.03.012 SUMMARY: THE PREVALENCE OF ESSENTIAL TREMOR (ET) IS ABOUT 4% ABOVE 40 YEARS OF AGE. CHRONIC ALCOHOL CONSUMPTION IS PRESENT IN AROUND 20% OF PATIENTS WITH ET. OUR OBJECTIVE WAS TO IDENTIFY WHETHER CHRONIC ALCOHOL CONSUMPTION WAS ASSOCIATED WITH A NEGATIVE EFFECT ON TREMOR OUTCOME AFTER THALAMIC DEEP BRAIN STIMULATION (DBS) IN ET PATIENTS. REPORTED EVENT: AN UNKNOWN NUMBER OF PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR (ET) REQUIRED A REVISION OF THEIR PROCEDURE. NO SPECIFIC DEVICE INFORMATION FOR THIS EVENT WAS PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631123 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention