BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX PERMANENT PACING LEAD

    MDR report key: 9411093 · Received December 4, 2019

    Report

    Report Number
    1035166-2019-00114
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    September 25, 2019
    Report Date
    December 5, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K862966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 1

    THE LEAD IS STILL IMPLANTED AND USED FOR TREATMENT. THE DEVICE REMAINS IN SERVICE FOR APPROXIMATELY 24 YEARS SINCE THE REPORTED LEAD BEING LISTED AS ACTIVE FROM (B)(6) 1995. NO ALLEGATION OUR DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR CAUSED OR CONTRIBUTED TO THE INFECTION OR POCKET EROSION. INFECTION IS A RECOGNIZED CLINICAL EVENT REFERENCED IN THE DEVICE'S LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. BASED UPON THE YEARS OF IMPLANT (24 YEARS) THE DEVICE HISTORY RECORDS FOR THIS LEAD MODEL GOES BEYOND OSCOR'S RECORD RETENTION PERIOD. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. PER QUALITY ASSURANCE PROCEDURE FINAL LABELING/PACKAGING INSPECTION OF ALL PRODUCTS: 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 (IFU) FOR PERMANENT IMPLANTABLE PACING LEADS, INFORMS THE USER ACTIVE-FIXATION ENDOCARDIAL LEADS, PASSED TRANSVENOUS, 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. CARDIACTAMPONADE 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. IN ADDITION, THE IFU PROVIDES LEAD RELATED PROBLEMS INCLUDING, BUT ARE NOT LIMITED TO: FRACTURE, DISLODGEMENT, CARDIAC PERFORATION, MYOCARDIAL IRRITABILITY AT IMPLANT, TRANSVENOUS INTRODUCTION, THRESHOLD ELEVATION AND INFECTION. CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED LEAD EXTRACTION DUE TO INFECTION AND POCKET EROSION; CALLER STATED DOCTOR REPORTED BEING AT CLINIC FOLLOW-UP WITH COMPETITOR'S REP AND DEVICE WAS PARTIALLY EXPOSED FROM POCKET. DEVICE REMAINS IN SERVICE FOR APPROXIMATELY 24 YEARS. PATIENT WAS HOSPITALIZED AND REQUIRED MEDICAL INTERVENTION. PER ADDITIONAL INFORMATION FROM CUSTOMER, BASED ON MEDICAL RECORD'S, THE DEVICE AND THE LEADS ARE STILL ACTIVE-IMPLANTED. THERE WAS NO FIELD REPRESENTATIVE PRESENT DURING THE PROCEDURE TO CONFIRM A SYSTEM EXTRACTION. NO ADDITIONAL INFORMATION IS AVAILABLE. NO OTHER SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203198 RX PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. RX 58 TBV

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R