BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS-R LARGE

    MDR report key: 6227290 · Received January 5, 2017

    Report

    Report Number
    3005619263-2017-00001
    Event Type
    Death
    Date Received
    January 5, 2017
    Date of Event
    December 5, 2016
    Report Date
    November 2, 2018
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: MODEL: 439888, LEAD; IMPLANTED: (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE (B)(6) IS DECEASED ASSOCIATED TO SEPTIC SHOCK. IT WAS FURTHER REPORTED THE PATIENT HAD LEFT AND RIGHT CARDIAC FAILURE AND POLYORGANIC FAILURE. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. BLOOD CULTURES WERE FOUND TO BE NEGATIVE AND THE SOURCE OF THE SEPSIS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT FELT WEAKNESS AND HAD HYPOTENSION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ACCORDING TO A CLINICAL EVENTS COMMITTEE (CEC) ASSESSMENT THIS EVENT IS IMPLANT RELATED AND RELATED TO A CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) INFECTION IDENTIFIED AS ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10811 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133EU 16K10783

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death DTBC2QQ , CRT-D / 5076-52, LEAD / 6947M62, LEAD