BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 6920022 · Received October 6, 2017

    Report

    Report Number
    3005619263-2017-00050
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 21, 2017
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    UDI-DI
    00643169468795
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A COAGULASE-NEGATIVE STAPHYLOCOCCI INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703646 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 17E18084 00643169468795

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R A2DR01 IPG, 5076-58 LEAD, 5076-52 LEAD