BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 16854865 · Received May 2, 2023

    Report

    Report Number
    1035166-2023-00054
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 25, 2023
    Report Date
    November 15, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE LEAD WAS USED IN TREATMENT FOR APPROXIMATELY 19 YEARS, 2 MONTHS BEFORE BEING EXPLANTED ON (B)(6) 2023, FOR INFECTION. THERE WERE NO ALLEGATIONS REPORTED FOR THIS LEAD. INFECTION IS A KNOWN INHERENT RISK FOR THE IMPLANTABLE DEVICE(S). THIS LEAD IS SUPPLIED STERILE. THE FOLLOWING CONTROLS ARE IN PLACE TO ENSURE THE INTEGRITY OF THE STERILE LEAD AND IT'S PACKAGING. THE FINAL LABELING AND PACKAGING INSPECTION PROCEDURE INDICATES ALL LABELING AND PACKAGING WILL BE INSPECTED 100%. SHAKE THE OUTER TRAY BY HOLDING TAB OF OUTER TRAY TO ENSURE INNER TRAY IS LOOSE INSIDE THE OUTER TRAY. CHECK FOR FOREIGN MATERIAL AND TYVEK SEAL INTEGRITY. VERIFY THAT COLOR OF STERI-DOT CHANGED FROM BROWN TO GREEN. SEALED AREAS (TYVEK LID TO LIP OF TRAY) ARE CONTINUOUS AROUND ENTIRE PERIMETER OF TRAY. NO VOIDS, BREAKS, AND OR BUBBLES ALONG THE SEAL. THE ENTIRE SEAL SHOULD BE AT LEAST QUARTER INCH WIDE AND HAVE A FULL RIDGE. THE TYVEK PULL TAB MUST BE PROPERLY FOLDED INTO POSITION. EXAMINE THE SEAL AND BORDER FOR UNIFORMITY OF THE SEAL. CHECK FOR HOLES OR ANY OTHER DAMAGES THAT COULD VIOLATE STERILITY THE INSTRUCTIONS FOR USE PERMANENT LEADS GENERIC BOOKLET (IFU) INFORMS THE USER THAT OSCOR'S MEDICAL DEVICES MEET ALL APPLICABLE FEDERAL REGULATIONS AND PROPOSED REGULATIONS GOVERNING STERILIZATION PRIOR TO BEING RELEASED FROM OUR FACILITY. ALL OF OSCOR'S STERILIZED PRODUCTS HAVE CONSISTENTLY PASSED BIOCOMPATIBILITY TESTS PRIOR TO RELEASE AND SHIPMENT. BASED UPON OUR TESTING OF PRODUCTS STERILIZED IN THIS MANNER, OSCOR INC. IS CONFIDENT ITS PRODUCTS ARE SAFE FOR THEIR INTENDED USE. THIS PRODUCT IS STERILIZED PRIOR TO SHIPMENT. THE STERILITY IS COMPROMISED WHEN THE PACKAGE IS OPENED OR DAMAGED. OSCOR INC. DOES NOT ASSUME ANY LIABILITY OR RESPONSIBILITY FOR STERILIZATION BY A THIRD PARTY. IN ADDITION, THE IFU LISTS INFECTION AS AN ADVERSE EFFECT: INFECTION, LEAD MAY REQUIRE SURGICAL REMOVAL. AS WITH THE INTRODUCTION OF ANY FOREIGN OBJECT INTO THE BODY, VARIOUS FORMS OF INFECTION CAN ALSO RESULT FROM THE USE OF ENDOCARDIAL OR EPICARDIAL LEADS. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS AN ADVERSE EVENT THAT MAY REQUIRE SURGICAL REMOVAL OF THE LEAD. NO FURTHER FOLLOW-UP IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WENT TO HOSPITAL DUE TO EROSION. PATIENT HAD AN ERODED LEAD COMING OUT OF SKIN. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE PATIENT SIDE EFFECTS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATES THAT A REVISION WAS PERFORMED. THE SYSTEM WAS EXPLANTED ON (B)(6) 2023, AND A NON-BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. THE FIELD REPRESENTATIVE INDICATES THE RA LEAD WILL NOT BE RETURNED FOR ANALYSIS, THEREFORE, IT WAS LIKELY EITHER DISCARDED OR DESTROYED AT THE EXPLANTING FACILITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635698 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR.INC 4017

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Other