BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 7093906 · Received December 7, 2017

    Report

    Report Number
    3005619263-2017-00062
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    September 8, 2017
    Report Date
    December 7, 2017
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THAT APPROXIMATELY ONE MONTH POST IMPLANT OF IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM AND ABSORBABLE ENVELOPE THE PATIENT PRESENTED WITH INFLAMMATION, REDNESS AND PAIN AT THE IMPLANT SITE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED GENERAL DISCOMFORT, AND FEVER. A POCKET INFECTION WAS CONFIRMED WITH POSITIVE BLOOD CULTURES. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872905 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133INT 17C02036

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R EN1SR01 IPG, ABSORABLE ENEVELOPE