BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5857598 · Received August 9, 2016

    Report

    Report Number
    3007566237-2016-02907
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    June 1, 2016
    Report Date
    August 9, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MATHKOUR, M., GARCES, J., SCULLEN, T., HANNA, J., VALLE-GILER, E., KAHN, L., ARRINGTON, T., HOUGHTON, D., LEA, G., BIRO, E., BUI, C.J., SULAIMAN, O.A.R., SMITH, R.D. SHORT AND LONG-TERM OUTCOMES OF DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE PATIENTS 70-YEARS AND OLDER. WORLD NEUROSURGERY. 2016. 1878.JUN 10. DOI: 10.1016/J.WNEU.2016.06.001 SUMMARY: OUR SINGLE-CENTER STUDY RETROSPECTIVELY ASSESSED A PROSPECTIVE REGISTRY OF PARKINSON'S DISEASE (PD) PATIENTS TREATED WITH DEEP BRAIN STIMULATION (DBS) WHO WERE =(B)(6) AT THE TIME OF THEIR PROCEDURE. UNIVARIATE ANALYSES AND ONE SAMPLE PAIRED T-TEST WERE USED TO EVALUATE DATA. MOTOR SCORES WERE EVALUATED USING THE UNIFIED PARKINSON'S DISEASE RATING SCALE III (UPDRS III) AND THE EFFECTS ON MEDICATION REQUIREMENTS WERE EVALUATED USING LEVODOPA EQUIVALENCE DAILY DOSES (LEDD). REPORTED EVENTS: 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED AN INFECTION TWO WEEKS AFTER UNDERGOING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY (4 YEARS AFTER INITIAL DBS PLACEMENT). THE INS WAS REMOVED AND SUBSEQUENTLY REPLACED AFTER FOUR MONTHS. CULTURES DRAWN AT THE TIME OF HARDWARE REMOVAL GREW STAPHYLOCOCCUS EPIDERMIDIS. THERE WAS NO SPECIFIC DEVICE INFORMATION PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511682 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention