BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS-R LARGE

    MDR report key: 5527718 · Received March 25, 2016

    Report

    Report Number
    3005619263-2016-00006
    Event Type
    Death
    Date Received
    March 25, 2016
    Date of Event
    February 22, 2016
    Report Date
    August 10, 2018
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: RIGHT VENTRICULAR MDT-LEAD, IMPLANTED: UNKNOWN. THE MANUFACTURER, MODEL, SERIAL NUMBER AND IMPLANT DATE OF THE SYSTEM'S ASSOCIATED LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEAD ARE NOT KNOWN. 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

    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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: RIGHT ATRIAL (RA) LEAD, MEDTRONIC LEAD, IMPLANTED: UNKNOWN. 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 DIED DUE TO MULTI-ORGAN FAILURE DUE TO SEPTIC SHOCK SECONDARY TO A DEVICE POCKET INFECTION FROM STAPHYLOCOCCUS AUREUS. APPROXIMATELY THREE WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH ABSORBABLE ENVELOPE, THE PATIENT HAD PRESENTED WITH PAIN AT THE DEVICE POCKET SITE, FEVERS AND INTERMITTENT BODY SHIVERS. THE PATIENT ALSO EXPERIENCED SWELLING, REDNESS, WARMTH, AND PURULENT DRAINAGE AT THE DEVICE POCKET SITE. A LEAD WAS VISIBLE AT THE SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH ANTIBIOTICS. A SMALL INCISION WAS MADE AT THE SITE AND THE CAVITY WAS DRAINED AND BRIEFLY FLUSHED. TWO DAYS LATER THE CRT-D SYSTEM WAS EXPLANTED. A DRAIN WAS PLACED AT THE SITE. THE PATIENT WAS ALSO TREATED WITH NOREPINEPHRINE DUE TO HEMODYNAMIC INSTABILITY. THE PATIENT WAS DIAGNOSED WITH SEPTIC SHOCK. THE PATIENT ALSO EXPERIENCED BLEEDING AT THE SITE AND THE DRAIN WAS REPOSITIONED. A FEW DAYS AFTER THE SYSTEM WAS EXPLANTED THE PATIENT FURTHER EXPERIENCED ACUTE RENAL INSUFFICIENCY AND STOMACH PAIN RELATED TO A POSSIBLE ISCHEMIC ILEUS. THE ILEUS LATER DEVELOPED INTO A PERFORATION OF THE ILEUM WHICH REQUIRED SURGICAL INTERVENTION. THE PATIENT CONTINUED TO DECLINE, INCLUDING RESPIRATORY DETERIORATION, AND THE PATIENT LATER PASSED AWAY. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182619 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133EU 15J21643

    Patients

    Seq Age Sex Outcome Treatment
    1 Death