BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 13622211 · Received February 28, 2022

    Report

    Report Number
    2182207-2022-00341
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 28, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P96009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    FENOY AJ, CONNER CR. FRAMELESS ROBOT-ASSISTED VS FRAME-BASED AWAKE DEEP BRAIN STIMULATION SURGERY: AN EVALUATION OF TECHNIQUE AND NEW CHALLENGES. OPER NEUROSURG (HAGERSTOWN). 2022.10.1227/ONS.0000000000000059. THIRTY-FOUR CONSECUTIVE PATIENTS WHO UNDERWENT BILATERAL AWAKE FRAMELESS ROBOT-ASSISTED DBS WERE COMPARED WITH A PREVIOUS COHORT OF 30 PATIENTS WHO UNDERWENT FRAME-BASED SURGERY. PATIENT DEMOGRAPHICS, OPERATIVE TIMES, AND MER DATA WERE COLLECTED FOR BOTH COHORTS. TWO-DIMENSIONAL RADIAL ERRORS OF LEAD PLACEMENTS WERE CALCULATED.  THE USE OF A TRULY FRAMELESS ROBOTIC PLATFORM SUCH AS THE MAZOR RENAISSANCE (MAZOR ROBOTICS LTD) PRESENTED CHALLENGES WHEN IMPLEMENTING TECHNIQUES USED DURING AWAKE FRAME-BASED SURGERY. MAINTAINING GOOD ACCURACY, INTRAOPERATIVE REFERENCE IMAGING, AND LIMITED MER TRAJECTORIES WILL HELP INTEGRATE FRAMELESS ROBOT ASSISTANCE INTO THE AWAKE DBS SURGICAL WORKFLOW. REPORTED EVENTS: ONE PATIENT DEVELOPED AN EROSION OVER HIS RIGHT FRONTAL INCISION LEADING TO EXPOSURE OF THE ELECTRODE AT POSTOPERATIVE DAY 40, WHICH SUBSEQUENTLY LED TO COMPLETE EXPLANTATION OF THE SYSTEM AND A COURSE OF ANTIBIOTICS (1/28 HEMORRHAGE, 1/28 EROSION/INFECTION). ONE PATIENT EXPERIENCED A SMALL TRACK INTRAPARENCHYMAL HEMORRHAGE THAT CAUSED TRANSIENT FACIAL DROOPING AND DYSARTHRIA INTRAOPERATIVELY, WHICH WAS FULLY RESOLVED BY THE 2-WK POSTOPERATIVE VISIT. 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
    943082 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention