BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 11976049 · Received June 10, 2021

    Report

    Report Number
    3005619263-2021-00022
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 30, 2021
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 APPROXIMATELY THREE WEEKS POST LEAD REVISION PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. IT WAS NOTED THAT UPON OPENING THE POCKET DURING THE LEAD REVISION PROCEDURE, THE PHYSICIAN NOTICED A BROWNISH DISCOLORATION OF THE POCKET FLOOR AND BROWNISH GEL-LIKE MATERIAL. IT WAS NOT KNOWN WHETHER THE FINDINGS REPRESENTED A PREVIOUS HEMATOMA OR LATENT INFECTION. THE POCKET WAS VIGOROUSLY IRRIGATED WITH SALINE AND ANCEF AND AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS USED. WOULD CULTURES WERE NEGATIVE. THE PATIENT RECEIVED FOURS DOSES OF ANCEF POSTOPERATIVELY AND DISCHARGED ON A COURSE OF KEFLEX. APPROXIMATELY THREE WEEKS POST LEAD REVISION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A WARM, RED, FLUCTUANT DEVICE POCKET. THE PATIENT WAS AFEBRILE WITHOUT LEUKOCYTOSIS. BLOOD CULTURES WERE OBTAINED AND NEGATIVE AND ANTIBIOTICS WAS ADMINISTERED. THE POCKET OPENED SPONTANEOUSLY WITH PURULENT DRAINAGE. WOUND CULTURES WERE OBTAINED AND PENDING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED, AND A SINGLE CHAMBER PACEMAKER WAS REQUESTED FOR EXTERNAL PACING SUPPORT UNTIL THE PATIENT IS CLEARED FOR A NEW SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874072 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122 R141377

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R DTMA1QQ CRTD, 6935M62 LEAD, 429888 LEAD