BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS

    MDR report key: 3840545 · Received May 30, 2014

    Report

    Report Number
    2182208-2014-01203
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: CARDIAC IMPLANTABLE ELECTRONIC DEVICE INFECTIONS: INCIDENCE, RISK FACTORS, AND THE EFFECT OF THE AIGISRX ANTIBACTERIAL ENVELOPE. HEARTRHYTHM. 2014;11(4):595-601. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. THE DATE OF DEATH IS NOT KNOWN AND IS ESTIMATED BASED ON THE PUBLICATION DATE. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE POUCH. MULTIPLE PATIENTS AND MULTIPLE ADVERSE EVENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING ADVERSE EVENTS: INFECTION AND DEATHS. THE STATUS OF EACH POUCH IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318839 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AE

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death