BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIGHT

    MDR report key: 19953573 · Received August 9, 2024

    Report

    Report Number
    3012165443-2024-00021
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    August 2, 2024
    Report Date
    November 5, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. ANALYSIS OF THE BURR HOLE DEVICE (LOT: 082M31023) FOUND THE BASE AND SCREW WERE DAMAGED - OVER TORQUE DAMAGED WERE FOUND ON THE TOP OF THE BONE SCREWS HEAD. OVER TORQUE DAMAGED ON ONE OF THE BONE SCREW HOLE ON THE RETURNED BASE. 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

    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 ONE OF THE SCREW HOLES IS TOO BIG ON THE BURR HOLD DEVICE. THE SCREW WENT THROUGH THE HOLE AND STOPPED ON THE SKULL, NOT ON THE WHOLE RING. NO PATIENT SIGNS AND SYMPTOMS. NO PATIENT FACTORS LED TO THE ISSUE. THE BURR HOLE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515813 SENSIGHT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY QUALITY TECH SERVICES LLC B32000 082M31023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention