BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPS

    MDR report key: 20191380 · Received September 11, 2024

    Report

    Report Number
    3012165443-2024-00026
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 24, 2024
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    JXG
    PMA / PMN Number
    K042359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    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

    MEDTRONIC RECEIVED INFORMATION REGARDING A SUBDURAL EVACUATION PORT SYSTEM (SEPS). IT WAS REPORTED THAT THE HEX BAR PROVIDED TO ADJUST THE GUARD ON THE DRILL WAS THE WRONG SIZE, AND IT DID NOT FIT IN THE SCREW FOR THE GUARD. A NEW KIT WAS WAS ALMOST OPENED JUST FOR A STERILE HEX BAR, HOWEVER, THE SITE WAS ABLE TO ADJUST THE SCREW USING A PICK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601000 SEPS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG QUALITY TECH SERVICES LLC 11-0401-CE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male