BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER PASSER

    MDR report key: 12598490 · Received October 8, 2021

    Report

    Report Number
    2182207-2021-01751
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    October 1, 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

    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 (HCP) REGARDING AN ISSUE WITH A CATHETER PASSER. IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE PERFORMED BY INSPIRE MEDICAL SYSTEMS, THE MEDTRONIC CATHETER PASSER 8591-38 WAS USED OFF-LABEL FOR TUNNELING, AND DURING TUNNELING THE PHYSICIAN HIT A VESSEL. THE PHYSICIAN NEEDED TO CAUTERIZE THE VESSEL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE PERFORMED BY INSPIRE MEDICAL SYSTEMS, THE MEDTRONIC CATHETER PASSER 8591-38 WAS USED OFF-LABEL FOR TUNNELING, AND DURING TUNNELING THE PHYSICIAN HIT A VESSEL. THE PHYSICIAN NEEDED TO CAUTERIZE THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495162 CATHETER PASSER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8591-38

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other