BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5672722 · Received May 23, 2016

    Report

    Report Number
    3007566237-2016-02071
    Event Type
    Injury
    Date Received
    May 23, 2016
    Date of Event
    March 28, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. 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

    LEE, W.W., EHM, G., YANG, H.J., SONG, I.H., LIM, Y.H., KIM, M-R., KIM, Y.E., HWANG, J.H., PARK, H.R., LEE, J.M., KIM, J.W., KIM, H-J., KIM, C., KIM, H.C., PARK, E., KIM, I.Y., KIM, D.G., JEON, B., PAEK, S.H. BILATERAL DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS UNDER SEDATION WITH PROPOFOL AND FENTANYL. PLOS ONE. 2016. 11(3):E0152619. DOI:10.1371/JOURNAL.PONE.0152619 SUMMARY: AWAKENING DURING DEEP BRAIN STIMULATION (DBS) SURGERY MAY BE STRESSFUL TO PATIENTS. THE AIM OF THE CURRENT STUDY WAS TO EVALUATE THE EFFECT ON MER SIGNALS AND THEIR APPLICABILITY TO SUBTHALAMIC NUCLEUS (STN) DBS SURGERY FOR PATIENTS WITH PARKINSON'S DISEASE (PD) UNDER SEDATION WITH PROPOFOL AND FENTANYL. REPORTED EVENTS: PATIENT 3: A (B)(6) FEMALE PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED A WOUND INFECTION WHICH WAS IMPROVED WITH ANTIBIOTICS AND WOUND REVISION. THE AUTHORS REPORTED ALL PATIENTS WERE IMPLANTED WITH BILATERAL IMPLANTABLE NEUROSTIMULATORS (INS) UNDER EACH CLAVICLE, BUT 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
    328109 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention