BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 6919694 · Received October 6, 2017

    Report

    Report Number
    3005619263-2017-00049
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    May 1, 2017
    Report Date
    July 6, 2017
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 20066 LEAD, IMPLANTED: (B)(6) 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT OF THE ANTIBACTERIAL ENVELOPE, THE PATIENT DEVELOPED A HEMATOMA, INFECTION, AND THERE WAS EROSION. THE PATIENT WAS TREATED WITH ANTIBIOTICS, THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703466 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R C2TR01 IPG, 5076-52 LEAD, 5076-58 LEAD