BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R MEDIUM

    MDR report key: 6919752 · Received October 6, 2017

    Report

    Report Number
    3005619263-2017-00048
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    July 4, 2017
    Report Date
    July 5, 2017
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT FOR ULCERATION OF THE SKIN WITH SLIGHT LIQUID FLOW AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND A POSSIBLE INFECTION. THE PATIENT WAS STARTED ON ANTIBIOTICS. ONE WEEK LATER, THE DEVICE HAD ERODED THROUGH THE SKIN AND WAS VISIBLE. THE IPG WAS EXPLANTED AND REPLACED , THE STATUS OF THE RIGHT ATRIAL (RA) LEAD IS UNKNOWN, AND THE STATUS OF THE ABSORBABLE ANTIBACTERIAL ENVELOPE 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
    704467 AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122CA 16G20747

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R SESR01 IPG, 407458 LEAD