BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER PASSER

    MDR report key: 14454847 · Received May 20, 2022

    Report

    Report Number
    2182207-2022-00834
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    September 10, 2021
    Report Date
    April 1, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    B5. CORRECTION WAS MADE TO THIS FIELD. 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING AN IMPLANTABLE PUMP. THE HEALTHCARE PROVIDER REPORTED THAT THEY HAD PERFORMED A INSPIRE MEDICAL SYSTEM IMPLANT ON A PATIENT AND HAD USED THE 8591-38 CATHETER (LOT # ASKED AND WAS UNKNOWN) PASSER TO TUNNEL. DURING THE TUNNELING, THE HEALTHCARE PROVIDER HAD STRUCK A VESSEL AND IT WAS BLEEDING. THE HEALTHCARE PROVIDER APPLIED PRESSURE FOR ABOUT 5 MINUTES AND THE BLEEDING STOPPED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A CATHETER PASSER. THE HEALTHCARE PROVIDER REPORTED THAT THEY HAD PERFORMED A INSPIRE MEDICAL SYSTEM IMPLANT ON A PATIENT AND HAD USED THE 8591-38 CATHETER (LOT # ASKED AND WAS UNKNOWN) PASSER TO TUNNEL. DURING THE TUNNELING, THE HEALTHCARE PROVIDER HAD STRUCK A VESSEL AND IT WAS BLEEDING. THE HEALTHCARE PROVIDER APPLIED PRESSURE FOR ABOUT 5 MINUTES AND THE BLEEDING STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269085 CATHETER PASSER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8591-38

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other