BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 11619367 · Received April 6, 2021

    Report

    Report Number
    3005619263-2021-00015
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 6, 2021
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 DEVELOPED A POCKET INFECTION APPROXIMATELY FIVE WEEKS POST THE IMPLANTATION OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WITH A ANTIBACTERIAL ABSORBABLE ENVELOPE. THE IPG SYSTEM WAS REMOVED. CULTURES WERE TAKEN AND MEDICATION WAS ADMINISTERED. AS THE PATIENT WAS DEPENDENT AN EXTERNAL TEMPORARY PACING DEVICE WAS USED. SIX DAYS LATER A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520889 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R W1DR01 IPG, 5076-52 LEAD, 5076-45 LEAD