BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 6060318 · Received October 27, 2016

    Report

    Report Number
    3005619263-2016-00046
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 22, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BIOTRONIK LEAD IMPLANT: (B)(6) 2012, BIOTRONIK LEAD IMPLANT: (B)(6) 2012. 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 AN INFECTION AND DRAINAGE WAS NOTED AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM AND ABSORBABLE ENVELOPE IMPLANT SITE. THE PATIENT WAS SEEN ON APPROXIMATELY ONE MONTH POST OPERATIVE AND A SMALL AMOUNT OF SWELLING AND REDNESS. A DIME SIZED AREA OF ESCHAR WAS NOTED AND SUSPECTED TO BE DUE TO A POSSIBLE REACTION FROM THE TAPE AT THE SITE PREVIOUSLY. AT THE PATIENT'S TWO MONTH FOLLOW UP VISIT, THE INCISION SITE APPEARED TO BE HEALING WELL AND THE SWELLING HAD RESOLVED BUT THE ESCHAR REMAINED. APPROXIMATELY TEN DAYS AFTER THAT VISIT, IT WAS NOTED THE ESCHAR AREA OPENED UP WITH A SCANT AMOUNT OF SEROSANGUINOUS AMOUNT OF DRAINAGE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT IS A PARTICIPANT IN THE WRAP-IT 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
    711669 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 15M11676

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 429888 LEAD, DTBA1Q1 CRT-D