BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIGHT

    MDR report key: 12086391 · Received June 29, 2021

    Report

    Report Number
    3012165443-2021-00006
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 28, 2021
    Report Date
    June 29, 2021
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    MHY
    UDI-DI
    00763000426521
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MIDDLE OF A BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IMPLANT, THE PHYSICIAN COULD NOT GET THE FINAL CAP/COVER TO FULLY ATTACH TO THE BURR HOLE DEVICE. THE PATIENT HAD A SMALL SKULL CAUSING GREATER THAN NORMAL CURVATURE. THEY TRIED TO UNLOCK AND LOCK THE SCISSOR MECHANISM TO MAKE SURE IT WAS FULLY LOCKED AND TRIED CLICKING THE COVER DOWN A DOZEN TIMES. THE PHYSICIAN DECIDED NOT TO USE THE COVER AND PUT A DOG BONE DOWN NEXT TO THE BURR HOLE DEVICE TO HOLD THE LEAD. THE FIRST SIDE WENT AS PLANNED. THEY THEN RAN AN IMPEDANCE TEST AND ALL LOOKED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986623 SENSIGHT MHY QUALITY TECH SERVICES LLC B32000 082M10921 00763000426521

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR