BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R MEDIUM

    MDR report key: 6163818 · Received December 9, 2016

    Report

    Report Number
    3005619263-2016-00050
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 11, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: ADDRL1 IPG IMPLANTED: (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. REDNESS AND PURULENT DRAINAGE WAS NOTED AT THE INCISION SITE. THE PATIENT WAS TREATED WITH KEFLEX AND BACTROBAN. IT WAS LATER REPORTED THE INFECTION HAD RESOLVED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812127 AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122 16J03762

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 5076-45 LEAD, 5076-52 LEAD