BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYRX BRAND AIGISRX ANTIBACTERIAL ENVELOPE

    MDR report key: 3350805 · Received May 20, 2013

    Report

    Report Number
    3005619263-2013-00002
    Event Type
    Other
    Date Received
    May 20, 2013
    Manufacturer
    TYRX INC
    Product Code
    FTL
    PMA / PMN Number
    063091
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    TYRX BRAND AIGISRX ANTIBACTERIAL ENVELOPES ARE INTENDED TO BE IMPLANTED IN CONJUNCTION WITH A PULSE GENERATOR SUCH AS A PACEMAKER OR ICD. THE INTENDED USE IS TO IMPLANT THE COMPLETE AIGIS DEVICE CONTAINING THE PULSE GENERATOR. TYRX DOES NOT RECOMMEND CUTTING THE ENVELOPE INTO FRAGMENTS PRIOR TO IMPLANTATION. THE DEVICE REPORTED IN THIS INCIDENT WAS CUT INTO 3/4 INCH FRAGMENTS AND THE FRAGMENTS WERE IMPLANTED IN THE TISSUE POCKET, WHICH TYRX CONSIDERS AN OFF-LABEL USE. THIS EVENT WILL BE FOLLOWED-UP AND ADDITIONAL INFO WILL BE SUBMITTED AS IT IS RECEIVED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223729 TYRX BRAND AIGISRX ANTIBACTERIAL ENVELOPE AIGISRX ENVELOPE FTL TYRX INC

    Patients

    Seq Age Sex Outcome Treatment
    1 RIFAMPIN 16 MG| MINOCYCLINE 16 MG