BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5667530 · Received May 19, 2016

    Report

    Report Number
    3007566237-2016-02054
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    January 1, 2016
    Report Date
    May 19, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PT GENDER: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. 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

    AKRAM, H., MILLER, S., LAGRATA, S., HYAM, J., JAHANSHAHI, M., HARIZ, M., MATHARU, M., ZRINZO, L. VENTRAL TEGMENTAL AREA DEEP BRAIN STIMULATION FOR REFRACTORY CHRONIC CLUSTER HEADACHE. NEUROLOGY. 2016. 86:1¿7. SUMMARY: TO PRESENT OUTCOMES IN A COHORT OF MEDICALLY INTRACTABLE CHRONIC CLUSTER HEADACHE (CCH) PATIENTS TREATED WITH VENTRAL TEGMENTAL AREA (VTA) DEEP BRAIN STIMULATION (DBS). REPORTED EVENTS: 1. 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) OF THE VENTRAL TEGMENTAL AREA (VTA) FOR CHRONIC CLUSTER HEADACHE (CCH) DEVELOPED A SUPERFICIAL WOUND INFECTION THAT RESOLVED WITH ANTIBIOTICS TREATMENT. IT WAS REPORTED THAT ALL PATIENTS WERE IMPLANTED WITH MODEL 3389 LEAD(S) AND EITHER A "SINGLE OR DUAL CHANNEL" IMPLANTABLE NEUROSTIMULATOR. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321571 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention