BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIGISRX R RESORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 3522805 · Received October 21, 2013

    Report

    Report Number
    3005619263-2013-00003
    Event Type
    Other
    Date Received
    October 21, 2013
    Date of Event
    September 1, 2013
    Report Date
    September 20, 2013
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS HOSPITALIZED FOR A WOUND CARE CONSULTATION ON (B)(6) 2013. THE USER CAN NEITHER ATTRIBUTE NOR COMPLETELY RULE OUT A REACTION TO THE AIGIS R ENVELOPE. THIS IS SUSPECTED TO BE A REACTION TO THE ENVELOPE OR TO THE ANTIBIOTICS IN THE COATING OF THE DEVICE. THE PT HAD NO KNOWN PREVIOUS EXPOSURE TO MINOCYCLINE OR RIFAMPIN. IN ADDITION, REACTIONS RESORBABLE SUTURES ARE WELL KNOWN. THE MFR BELIEVES THIS WAS A SUSPECTED REACTION TO THE ANTIBIOTICS OR THE RESORBABLE MESH. IT IS ALSO POSSIBLE IT WAS RELATED TO THE POCKET WAS WITH BACITRACIN. ADDITIONAL INFO WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A (B)(6) WM WITH CORRECTED TRANSPOSITION OF THE GREAT VESSELS PRESENTED ON (B)(6) 2013 FOR REPLACEMENT OF HIS PERMANENT PACEMAKER (PM) THAT WAS IMPLANTED IN THE LEFT INFRACLAVICULAR FOSSA. THE PT ALSO HAD A HISTORY OF DIABETES MELLITUS. NO KNOWN DRUG ALLERGIES. NO KNOWN PRIOR EXPOSURE TO MINOCYCLINE OR RIFAMPIN. AT THE PROCEDURE THE PT'S SKIN WAS WASHED WITH EITHER CHLORHEXIDINE OR POVACRYLEX AND ISOPROPYL ALCOHOL (3M DURAPREP SOLUTION). PERIOPERATIVE INTRAVENOUS VANCOMYCIN WAS ADMINISTERED. THE PM GENERATOR WAS REPLACED WITHOUT COMPLICATION. BEFORE THE INCISION WAS CLOSED, THE POCKET WAS WASHED WITH A SOLUTION OF BACITRACIN PREPARED BY ADDING A VIAL OF BACITRACIN TO 500 ML OF NORMAL SALINE. APPROXIMATELY 5 DAYS AFTER THE IMPLANTATION PROCEDURE, THE PT DEVELOPED SWELLING OVER THE IMPLANT SITE, PLEURITIC CHEST PAIN (POSTERIOR GREATER THAN ANTERIOR, LEFT GREATER THAN RIGHT) THAT WAS WORSE IN THE SUPINE POSITION AND LESSENED BY SITTING UPRIGHT. THE PT WAS SEEN IN THE ELECTROPHYSIOLOGY CLINIC THE NEXT DAY. HE WAS AFEBRILE, NO LOCAL OR SYSTEMIC RASH, SEROUS FLUID COULD BE EXPRESSED FROM THE INCISION SITE THAT REVEALED DEHISCENCE OF SKIN LAYER OF SUTURES (TWO DEEPER) LAYERS WERE INTACT). NO LEUKOCYTOSIS, NO INFILTRATE OR PLEURAL EFFUSION ON CXR, AND ULTRASOUND OF THE POCKET DID NOT REVEAL A FLUID COLLECTION IN OR OVER THE POCKET. PT PRESCRIBED ORAL KEFLEX AND NSAIDS. DISCOMFORT AND FLUID COLLECTION SUBSIDED OVER THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539332 AIGISRX R RESORBABLE ANTIBACTERIAL ENVELOPE AIGIS R ANTIBACTERIAL ENVELOPE FTL TYRX, INC. CMRM6122US 13H02363

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization