BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 20108387 · Received August 30, 2024

    Report

    Report Number
    2182208-2024-03744
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 30, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: SUCCESSFUL EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTATION IN A PATIENT WITH RECURRENT TRANSVENOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR EROSION. HEART RHYTHM O2. 2024; 5:243¿245. DOI: 10.1016/J.HROO.2024.02.007. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTATION WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE AUTHORS DESCRIBED A PATIENT WHO PRESENTED TO THE CLINIC APPROXIMATELY SEVEN MONTHS POST IMPLANT AFTER THEY NOTED A SMALL ABRASION AT THE INCISION AND THE DEVICE WAS VISIBLE. THE PATIENT WAS ADMITTED FOR A DEVICE REPLACEMENT. THERE WAS NO PURULENT DRAINAGE, ERYTHEMA, OR INDURATION OF THE INCISION. THE PATIENT WAS GIVEN ANTIBIOTICS AND REIMPLANTED WITH ANOTHER ANTIBACTERIAL ABSORBABLE ENVELOPE. APPROXIMATELY NINE DAYS FOLLOWING THIS IMPLANT, THE PATIENT PRESENTED TO THE HOSPITAL WITH PURULENT DRAINAGE FROM THE INCISION SITE AND A SUTURE WAS PROTRUDING FROM THE INCISION AND WAS REMOVED. STERILIZED STRIPS WERE ADDED, AND DOXYCYCLINE WAS PRESCRIBED. TWENTY-FIVE DAYS LATER THEY PRESENTED AGAIN WITH VISIBLE HARDWARE THROUGH INCISIONAL DEHISCENCE. THE DEVICE WAS REMOVED, AND THE PATIENT WAS REFERRED FOR AN EXTRAVASCULAR ICD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597151 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL MEDTRONIC, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R