BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS-R LARGE

    MDR report key: 6274902 · Received January 24, 2017

    Report

    Report Number
    3005619263-2017-00002
    Event Type
    Death
    Date Received
    January 24, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 9, 2017
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: 5076-52 LEAD, IMPLANTED: (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A POCKET HEMATOMA. THE HEMATOMA WAS EVACUATED, THE POCKET WAS REVISED, AND AN ANTIBACTERIAL ENVELOPE WAS IMPLANTED. FOLLOWING, THE PATIENT DEVELOPED A POCKET INFECTION AND THE IMPLANTABLE PULSE GENERATOR (IPG)) SYSTEM WAS REMOVED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. IT WAS LATER LEARNED THE PATIENT IS DECEASED. ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS LEARNED FROM THE PHYSICIAN THAT WHILE THE CAUSE OF DEATH IS NOT KNOWN, IT WAS MULTI-FACTORIAL WITH AN ASSOCIATION TO THE INFECTION. THE PATIENT HAD A HISTORY OF DISSEMINATED INTRAVASCULAR COAGULATION AND WAS PLACED ON DO NOT RESUSCITATE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55655 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 16L15801

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death| H| R VEDR01 IPG