BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAFIX S2J 748

    MDR report key: 8843235 · Received July 30, 2019

    Report

    Report Number
    1035166-2019-00063
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 2, 2019
    Report Date
    September 13, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K013339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: B4, G4, G7, H2, H6 AND H10 THE LEAD IS IN USE FOR TREATMENT. THE LEAD IS IN SERVICE FOR APPROXIMATELY 11 YEARS, 8 MONTHS; IT WILL NOT RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION 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 LOCATION OF THE LEAD IS UNKNOWN. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, HOWEVER THEY WERE NOT SUCCESSFUL. THE PROCEDUE FOR THIS LEAD INDICATES THE LEAD IS CHECKED 100 % FOR THE FOLLOWING: LENGTH MEASUREMENT, DISTAL SPACING IS MEASURED, CHECKING THE ELECTRICAL DC RESISTANCE ON LEADS FROM RING TO RING, PIN TO TIP AND PIN TO RING, PULL TEST ON CONNECTOR TO VERIFY WELDING, "D" DIMENSION ON IS-CONNECTOR IS MEASURED, HELIX OPERATION AND FUNCTION IS TESTED, AND A FINAL COSMETIC INSPECTION IS DONE ON THE WHOLE LEAD FROM PROXIMAL END TO DISTAL END UNDER 10X MAGNIFICATION. FINAL QA INSPECTION IS DONE ON THE FIRST AND LAST SERIAL NUMBERS OF THE WORK ORDER FOR INSERTION/WITHDRAWAL FORCE TEST ON THE IS-1 CONNECTOR. AS PER THE PHYSICIAN'S MANUAL IT INFORMS THE USER OF POSSIBLE COMPLICATIONS: WITH THE USE OF ENDOCARDIAL LEADS, COMPLICATIONS MIGHT OCCUR DURING IMPLANTATION, EXPLANTATION OR AT ANY TIME POSTOPERATIVELY AND MAY REQUIRE NON-INVASIVE OR INVASIVE TECHNIQUES FOR MANAGEMENT, AS DETERMINED BY THE CLINICAL JUDGMENT OF THE PHYSICIAN. INTERMITTENT OR CONTINUOUS LOSS OF PACING OR SENSING CAN BE CAUSED BY DISPLACEMENT OF THE ELECTRODE, UNSATISFACTORY ELECTRODE POSITION, BREAKAGE OF THE CONDUCTOR OR ITS INSULATION, AN INCREASE IN THRESHOLDS OR POOR ELECTRICAL CONNECTION TO THE PULSE GENERATOR. LEADS MAY FAIL TO FUNCTION FOR A VARIETY OF CAUSES, INCLUDING MEDICAL COMPLICATIONS, BODY REJECTION PHENOMENON, ALLERGIC REACTION, FIBROTIC TISSUE PROBLEM, OR A FAILURE OF LEAD BY DAMAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION. IN ADDITION, IT PROVIDES THE FOLLOWING: CLINICAL EVIDENCE SUGGESTS THAT CERTAIN UPPER EXTREMITY ACTIVITIES ARE CONTRAINDICATED FOR PERSONS WITH PERMANENT PACEMAKERS BECAUSE THEY REQUIRE MOVEMENTS THAT CAN CAUSE DAMAGE TO THE LEADS AND POSSIBLE FAILURE OF THE LEADS. ACTIVE PEOPLE, PARTICULAR THOSE WHO PERFORM REPETITIVE UPPER EXTREMITY EXERCISE AT WORK OR PLAY SHOULD BE CAUTIONED THAT THEY COULD SUBJECT LEADS TO DAMAGING STRESS. BE SURE TO LEAVE SUFFICIENT SLACK IN THE LEAD TO COMPENSATE FOR BODY MOVEMENTS. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION B4: INITIAL DATE OF THE REPORT SHOULD OF BEEN (B)(6) 2019 (NOT (B)(6) 2018) 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

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    LEAD NOISE OBSERVED ON THE RIGHT ATRIAL LEAD CAUSING INAPPROPRIATE MODE SWITCHING. THE INFORMATION WAS REPORTED BY AN ABBOTT REPRESENTATIVE. THE LEAD WILL NOT BE RETURNED. NOTE: THE EVENT DATE WAS NOT PROVIDED, SO OSCOR IS USING THE DATE THIS COMPLAINT WAS RECEIVED AS THE EVENT DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638286 ELAFIX S2J 748 PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ELAFIX S2J 748 C3-04897

    Patients

    Seq Age Sex Outcome Treatment
    1