BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIGHT

    MDR report key: 20184933 · Received September 10, 2024

    Report

    Report Number
    3012165443-2024-00023
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 25, 2024
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE BURR HOLE DEVICE (SERIAL #: (B)(6)) REVEALED THAT THE BURR HOLE CAP WAS DAMAGED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSPARENT LID PORTION OF THE BURR HOLE DEVICE WAS INSTALLED, BUT IT COULD NOT BE INSTALLED PROPERLY, SO WHEN THE PRODUCT WAS CHECKED, IT BECAME CLEAR THAT THE CLAW PORTION OF THE LID WAS BROKEN. NO ENVIRONMENT, EXTERNAL, AND PATIENT FACTORS THAT MAY HAVE CAUSED THE EVENT WERE IDENTIFIED. THEY TRIED SEVERAL TIMES TO FIX IT, BUT IT DID NOT WORK BECAUSE THE CLAW PORTION WAS BROKEN. IT WAS REPLACED WITH ANOTHER PRODUCT. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296218 SENSIGHT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY QUALITY TECH SERVICES LLC B32000 082M03324A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention