BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 19409709 · Received May 28, 2024

    Report

    Report Number
    1282497-2024-00139
    Event Type
    Death
    Date Received
    May 28, 2024
    Date of Event
    December 5, 2023
    Report Date
    May 28, 2024
    Manufacturer
    COVIDIEN LLC
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT PRODUCTS: UNK DY, DIALYSIS UNKNOWN (LOT#:UNKNOWN), UNK DY, DIALYSIS UNKNOWN (LOT#:UNKNOWN) (B)(6): BACTEREMIA AND MORTALITY AMONG PATIENTS WITH NONTUNNELED AND TUNNELED CATHETERS FOR HEMODIALYSIS. 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

    ACCORDING TO THE REPORTED A RETROSPECTIVE COHORT STUDY OF CATHETERS INSERTED BETWEEN JANUARY 2011 AND DECEMBER 2020 EVALUATED THE BACTEREMIA AND CATHETER DYSFUNCTION RATES FOR NON-TUNNELED AND TUNNELED HEMODIALYSIS CATHETERS. THE NONTUNNELED CATHETERS USED WERE COMPETITOR DEVICES. TUNNELED CATHETER MODELS WERE 3 COMPETITOR¿S CATHETERS, AND 1 FROM OUR OWN CATHETER. A TOTAL OF 248 TUNNELED CATHETER WERE PLACED. THE AUTHORS DO NOT REPORT THE EXACT NUMBER OF DEATHS IN THE TUNNELED CATHETER GROUP. HOWEVER, THEY STATED A NINETY-DAY SURVIVAL RATE OF 96.8% INDICATING THERE WERE POSSIBILITY PATIENT DEATHS THAT OCCURRED IN THIS STUDY GROUP. NO INFORMATION WAS PROVIDED AS TO THE INTERVENTIONS REQUIRED. FURTHERMORE, THE AUTHORS STATED THAT THERE WAS A LACK OF INFORMATION INCLUDING CAUSES OF DEATH AND LACK OF INFORMATION ABOUT CATHETER TYPE INDICATION. BACTEREMIA AND MORTALITY AMONG PATIENTS WITH NONTUNNELED AND TUNNELED CATHETERS FOR HEMODIALYSIS: HINDAWI INTERNATIONAL JOURNAL OF NEPHROLOGY VOLUME 2024, ARTICLE ID 3292667.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308900 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Other| D SEE H11