BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 6164115 · Received December 9, 2016

    Report

    Report Number
    3005619263-2016-00054
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    April 22, 2016
    Report Date
    October 17, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 503452 LEAD, IMPLANTED: (B)(6) 1997; 4068-45 LEAD, IMPLANTED: (B)(6) 1997. 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

    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 A POCKET INFECTION AND VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD AFTER A DEVICE EXCHANGE PROCEDURE WITH AN ABSORBABLE ENVELOPE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND CULTURES WERE TAKEN. THE IMPLANTABLE PULSE GENERATOR (IPG) 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
    810844 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 16A07684

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R ADDR01 IPG