BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYRX BRAND AIGISRX ANTIBACTERIAL ENVELOPE - SMALL

    MDR report key: 3950785 · Received March 5, 2014

    Report

    Report Number
    3005619263-2014-00003
    Event Type
    Other
    Date Received
    March 5, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 4, 2014
    Manufacturer
    TYRX, INC
    Product Code
    FTL
    PMA / PMN Number
    K063091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED A PACEMAKER IN 1998. ON (B)(6) 2004 PATIENT RECEIVED A PACEMAKER CHANGE FOR DEPLETED BATTERY. AT THAT TIME, THE PATIENT WAS IN ATRIAL FIBRILLATION WITH COMPLETE HEART BLOCK AND WAS PACEMAKER DEPENDENT. ON (B)(6) 2005 PATIENT RECEIVED A CORONARY ARTERY DRUG-ELUTING STENT. ON (B)(6) 2013, PATIENT RECEIVED PACEMAKER CHANGE FOR DEPLETED BATTERY, AND A NEW LEAD. PATIENT WAS IN COMPLETE HEART BLOCK WITH NO UNDERLYING ESCAPE RHYTHM. THE PACEMAKER WAS IMPLANTED WITH AN AIGISRX ENVELOPE. PATIENT PRESENTED WITH PAIN AND SWELLING IN THE GENERATOR POCKET, AND WAS ADMITTED TO THE HOSPITAL. BLOOD AND WOUND CULTURES WERE NEGATIVE AND PATIENT WAS STARTED ON VANCOMYCIN. THE PACEMAKER WAS REMOVED AND CEFEPIME WAS ADDED. ON (B)(6) 2014, WOUND CULTURES GREW ENTEROBACTER CLOACAE. ON (B)(6) 2014, PACEMAKER EXPLANTED. POCKET INFECTION IS AN INHERENT RISK IN THIS PROCEDURE. ADDITIONAL INFORMATION ON THE RESOLUTION OF THIS EVENT WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    TYRX ANTIBACTERIAL ENVELOPE PLACED WITH CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED), PATIENT DIAGNOSED WITH A CIED INFECTION. PROCEDURE WAS A BATTERY CHANGE AND WAS BRIEF, INFECTION RISK CONSIDERED LOW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132862 TYRX BRAND AIGISRX ANTIBACTERIAL ENVELOPE - SMALL AIGISRX ANTIBACTERIAL ENVELOPE FTL TYRX, INC CMRM6122-US-S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization 11 MG MINOCYCLINE| 59 CM IS-1 BIPOLAR STEROID-ELUTING PACE/SENSE| RIGHT VENTRICULAR LEAD (ACTIVE): GUIDANT FLEXTEND| ENDOCARDIAL SILLICONE LEAD WITH LUBRICIOUS COATING| EXTENDABLE/RETRACTABLE HELIX, MODEL 4088| 11 MG RIFAMPIN| GENERATOR| BOSTON SCIENTIFIC INGENIO GENERATOR, MODEL K172 SR| (SERIAL #(B)(4))| SERIAL (B)(4)