BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 12934586 · Received December 6, 2021

    Report

    Report Number
    1035166-2021-00147
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    October 15, 2021
    Report Date
    February 28, 2022
    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.

    Additional Manufacturer Narrative · 0

    THE LEAD WAS IN USE FOR APPROXIMATELY 19 YEARS, 5 MONTHS BEFORE BEING EXPLANTED DUE TO AN INFECTION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE ALLEGATIONS AGAINST THIS LEAD (INFECTION) CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN PROCESS AND FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED ALLEGATIONS. 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. PER 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. THE PACING LEADS ARE IMPLANTED IN THE EXTREMELY HOSTILE ENVIRONMENT OF THE HUMAN BODY. LEADS ARE NECESSARILY SMALL IN DIAMETER AND MUST BE VERY FLEXIBLE, WHICH UNAVOIDABLY REDUCES THEIR POTENTIAL PERFORMANCE AND LONGEVITY. LEADS MAY FAIL TO FUNCTION FOR A VARIETY OF CAUSES, INCLUDING BUT NOT LIMITED TO MEDICAL COMPLICATIONS, BODY REJECTION PHENOMENON, ALLERGIC REACTION, FIBROTIC TISSUE, OR A FAILURE OF LEAD BY BREAKAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION. IN ADDITION DESPITE THE EXERCISE OF ALL DUE CARE IN DESIGN, COMPONENT SELECTION, MANUFACTURE AND TESTING PRIOR TO SALE, LEADS MAY BE DAMAGED BEFORE, DURING, OR AFTER INSERTION BY IMPROPER HANDLING, USE, PLACEMENT OR OTHER INTERVENING ACTS. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR, HOWEVER, 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 ISBASED 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

    THIS LEAD WAS PART OF A PACING SYSTEM EXPLANT PROCEDURE DUE TO INFECTION. NO KNOWN DEVICE PROBLEM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833180 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4017 C2-02683

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R