BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 8875131 · Received August 8, 2019

    Report

    Report Number
    2182208-2019-01464
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 22, 2019
    Report Date
    February 16, 2020
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 THE PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION A FEW WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WITH AN ABSORBABLE ENVELOPE. THE CRT-P SYSTEM WAS EXPLANTED. THE PATIENT LATER RECEIVED A LEADLESS PACEMAKER SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION A FEW WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WITH AN ABSORBABLE ENVELOPE. THE CRT-P SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670614 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 R114285

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R W4TR02 CRTP, 439878 LEAD, 5076-58 LEAD