BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 3992250 · Received August 8, 2014

    Report

    Report Number
    3005619263-2014-00004
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: PRODUCT ID 4592-45, IMPLANTED: 2005-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSSIBLE POCKET INFECTION OCCURRED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM REMAINS IN USE AND THE WOUND WAS TREATED PER PROTOCOL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471792 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R D274DRG ICD, 6935 LEAD