BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACING LEAD

    MDR report key: 15078932 · Received July 21, 2022

    Report

    Report Number
    1035166-2022-00088
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 17, 2022
    Report Date
    December 22, 2022
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K912867
    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 AND DEVICE WERE EXPLANTED DUE TO EXHIBITED INFECTION WITH SEPSIS AND POCKET EROSION. THE LEAD WAS IN SERVICE FOR APPROXIMATELY 28 YEARS, 7 MONTHS BEFORE BEING EXPLANTED ON (B)(6) 2022. QA IS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS FOR THIS LEAD MODEL AS IT IS BEYOND OSCOR'S RECORD RETENTION PERIOD, HOWEVER, INSPECTION PROCEDURES REQUIRE OSCOR PRODUCTS TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THE LEAD IMPLANT DATE IS 10/16/1993. THE LEAD WAS IN USE FOR TREATMENT. THERE WAS NO LEAD RELATED ISSUE REPORTED. THE LEAD WAS NOT RETURNED TO PERFORM AN ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD (INFECTION) CANNOT BE CONFIRMED. HOWEVER, THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. 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. VERIFY ALL STERILIZATION PROCESSES ACCEPTANCE CRITERIA WAS MET PER BIOLOGICAL INDICATORS/PROCESS CHALLENGE DEVICE TESTING PROCEDURE. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS AN ADVERSE EVENT THAT MAY REQUIRE SURGICAL REMOVAL OF THE LEAD. THE IFU LISTS GENERAL WARNINGS: ACTIVE-FIXATION ENDOCARDIAL LEADS. PASSED TRANSVENOUSLY. PRESENT THE POSSIBILITY OF INADVERTENTLY ENGAGING THE LEAD TIP WITH INTRACARDIAC STRUCTURES, SUCH AS THE TRICUSPID VALVE LEAFLETS OR CHORDAE TENDINEAE. LATERAL LEAD-TIP PLACEMENT IN THE ATRIUM OR PERFORATION OF THE VENTRICULAR OR LATERAL ATRIAL WALL MAY CAUSE PHRENIC NERVE STIMULATION. PERFORATION OF THE VENTRICLE MAY ALSO CAUSE DIAPHRAGMATIC MUSCLE STIMULATION. CARDIAC TAMPONADE HAS BEEN REPORTED FROM INSTANCES OF LEAD PERFORATION. 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, THE PATIENT (KC) WITH PULSE GENERATOR DEVICE L311/620953 EXHIBITED INFECTION WITH SEPSIS AND POCKET EROSION. NO PROCEDURES SCHEDULED AT THIS TIME. DEVICES REMAIN IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 WITH THE IMPLANT / EXPLANT DATES, AND WITH A DIFFERENT TYPE OF LEAD MODEL NUMBER. ORIGINALLY THE CUSTOMER REPORTED THE LEAD MODEL WAS UNKNOWN, AFTER SEARCHING THEIR PATIENT DATABASE THEY PROVIDED TWO DIFFERENT MODEL NUMBERS (ZY52PJSBV, PY52PBV). SINCE THERE ARE DISCREPANCIES, AS TO WHICH IS THE CORRECT LEAD MODEL NUMBER, IT IS NOW BEING CORRECTED AND BEING REPORTED AS A PERMANENT PACING LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88429 PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ZY 52 PJUSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R