BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 19146170 · Received April 19, 2024

    Report

    Report Number
    3005619263-2024-00004
    Event Type
    Death
    Date Received
    April 19, 2024
    Date of Event
    April 13, 2024
    Report Date
    April 19, 2024
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO DAYS AFTER THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT EXHIBITED AN SLIGHTLY INCREASED C-REACTIVE PROTEIN (CRP) MEASUREMENT. THE THIRD DAY, THE CRP MEASUREMENT HAD SIGNIFICANTLY INCREASED AND SEPSIS DEVELOPED, RESULTING IN THE PATIENT PASSING. THE ORIGIN OF THE INFECTION COULD NOT BE IDENTIFIED. IT WAS NOTED THAT THE PATIENT'S AGE, MULTIPLE CO-MORBIDITIES, AND THE LONG PROCEDURE DURATION MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE INFECTION THAT LEAD TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694782 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133INT R215955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death W4TR05 CRTP, 407652 LEAD, 479888 LEAD,