BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPS

    MDR report key: 20191095 · Received September 11, 2024

    Report

    Report Number
    3012165443-2024-00024
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 9, 2024
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    JXG
    UDI-DI
    00613994505217
    PMA / PMN Number
    K042359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SITE CHANGED THE PRODUCT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A SUBDURAL EVACUATION PORT SYSTEM (SEPS). IT WAS REPORTED THAT DURING THE PLACEMENT OF A DEEP VEIN THROMBOSIS (DVE), THE NEUROSURGERY INTERN HAD DIFFICULTY KEEPING THE SKIN RETRACTORS OPEN ON THE PATIENT WHILE THEY HELD WHEN TRYING OUT ON THE PATIENT. WHEN THEY WERE PUT IN PLACE, THEY WERE SYSTEMATICALLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567306 SEPS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG QUALITY TECH SERVICES LLC 11-0401-CE 096110923A 00613994505217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male