BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIGHT

    MDR report key: 20340708 · Received September 30, 2024

    Report

    Report Number
    3012165443-2024-00029
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 24, 2024
    Report Date
    October 15, 2024
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    MHY
    UDI-DI
    00763000426521
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE B32000 BURR HOLE DEVICE INSERTION TOOL (LOT NUMBER 082M03324) REVEALED A DAMAGED TIP. 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 BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THE CLEAR TOOL USED TO HOLD THE V-CLIP HAD ITS ¿METAL END¿ SPLIT AFTER THE SCRUB TECH ATTEMPTED TO PLACE IT IN THE V-CLIP. THE TOOL IS BEING SENT BACK FOR ANALYSIS. THIS INCIDENT OCCURRED ON THE BACK SCRUB TABLE AT THE BEGINNING OF THE PROCEDURE, SO THE TOOL WAS NEVER USED WITH THE PATIENT. THE REP STATED THEY KNEW NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS CONTRIBUTING TO THIS POTENTIAL ISSUE. THE SCRUB TECH TRIED MULTIPLE TIMES TO INSERT THE METAL END OF THE CLEAR TOOL. SUBSEQUENTLY, THEY SWITCHED TO THE NEXFRAME V-CLIP TOOL, WHICH WORKED WITHOUT ANY ISSUES. AS A RESULT, ANOTHER BURR HOLE DEVICE KIT CLEAR TOOL WAS OPENED SINCE THE PHYSICIAN USED THE STARFIX PLATFORM AND NEEDED THE CLEAR TOOL TO FIT UNDERNEATH THE PLATFORM. THE NEW KIT CLEAR TOOL FUNCTIONED CORRECTLY, RESOLVING THE ISSUE. AT THE TIME OF THIS REPORT, THE PROBLEM WAS RESOLVED, AND THE HEALTHCARE PROFESSIONAL (HCP) HAD NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45510 SENSIGHT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY QUALITY TECH SERVICES LLC B32000 082M03324 00763000426521

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female