BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIGHT

    MDR report key: 19667741 · Received July 3, 2024

    Report

    Report Number
    3012165443-2024-00015
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 26, 2024
    Report Date
    February 26, 2025
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3. ANALYSIS OF THE BURR HOLE DEVICE (LOT#: 082M01224A) DETERMINED THAT THE BURR HOLE DEVICE KIT WAS PACKAGED INCORRECTLY. 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.

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE OPERATION, NURSE WAS OPENING THE REPORTED BURR HOLE DEVICE FOR SURGEON, BUT DEFECT WAS SPOTTED. ONE OF THE SCREWS WAS NOT ATTACHED TO THE BURR HOLE BASE CAP BUT FREE FLOWING IN THE PACKAGE (WHICH SHOULD BE SIT IN THE BASE HOLDER NORMALLY). THE NO-SCREW SIDE OF THE BASE HOLDER IS FOUND LOSE AND CANNOT RE-HOLD THE SCREW. SURGEON FEELS UNSAFE WITH USING THE DEFECT CONSUMABLE. THE BURR HOLE DEVICE WAS NOT IMPLANTED INTO PATIENT, SO NO INJURY/DISCOMFORT. NO EXTERNAL FACTORS WERE REPORTED TO HAVE CAUSED THE ISSUE. SURGEON TRIED TO RESET THE FREE-FLOWING SCREW INTO THE BASE HOLDER, BUT FAILED AS THE PART OF THE SCREW SITS WAS ALREADY LOSE. A NEW SET OF BURR HOLE DEVICE WAS USED. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508234 SENSIGHT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY QUALITY TECH SERVICES LLC B32000 082M01224A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male