BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS

    MDR report key: 6006580 · Received October 6, 2016

    Report

    Report Number
    3005619263-2016-00041
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 9, 2018
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K142611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: CARDIAC IMPLANTABLE ELECTRONIC DEVICE INFECTION IN PATIENTS AT RISK. ARRHYTHMIA AND ELECTROPHYSIOLOGY REVIEW,. 2016;5(1):65-71. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING USING AN ENVELOPE WITH DEVICE IMPLANTATION. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WITH INFECTIONS NOTED. THE STATUS OF THE ENVELOPE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660637 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IPG/ICD