BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7325137 · Received March 8, 2018

    Report

    Report Number
    3007566237-2018-00708
    Event Type
    Death
    Date Received
    March 8, 2018
    Date of Event
    June 1, 2013
    Report Date
    March 8, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE LITERATURE ARTICLE; THIS DATE IS BASED ON THE DATE OF ARTICLE PUBLICATION. 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. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. COONS, S., SHI, J. GLIOBLASTOMA AND NEURODEGENERATIVE DISEASE Y A RETROSPECTIVE AUTOPSY REVIEW. J NEUROPATHOL EXP NEUROL. 2013; 72(6):560-561. DOI: 10.1097/NEN.0B013E318299610E. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY/REPORTED EVENTS: IN THE AUTHORS¿ RETROSPECTIVE AUTOPSY REVIEW THEY NOTED A PATIENT WHO HAD DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) FOR OVER 20 YEARS WITH GLIOBLASTOMA CENTERED ON THE DBS WIRE/TRACK. IT WAS NOT POSSIBLE TO ASCERTAIN 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
    165850 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death