BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 18092494 · Received November 8, 2023

    Report

    Report Number
    1035166-2023-00121
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    September 25, 2023
    Report Date
    November 13, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. BASED UPON THE IMPLANT DATE OF THIS LEAD (2001), THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL IS BEYOND OSCOR'S RECORD RETENTION PERIOD. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. IN CONCLUSION, BASED ON THE INFORMATION AVAILABLE AT THIS TIME IT CANNOT BE CONFIRMED THAT THE PRODUCT FAILED TO MEET REQUIREMENTS. 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

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT 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.

    Description of Event or Problem · 0

    HCP REQUESTING REVIEW OF THE PRESENTING EGM AND QUESTION RA CAPTURE AND EXTRA SIGNAL. NOTE RV LEAD IS FROM 1993 THAT HAS NEEDED REPAIRING AND RA LEAD FROM 2001. BOTH HAVE EXPERIENCED LSS DUE TO <200 OHMS IMPEDANCE. TS LOOKED AT THE PRESENTING EGM (OCT 27, 2023) WHICH DOES SHOW THAT THERE ARE EXTRA RA NON PHYSIOLOGIC SIGNALS THAT ARE BEING OVERSENSED. RA UNIPOLAR BUT DOES NOT LOOK LIKE MUSCLE NOISE RATHER THE SHARP DEFLECTIONS COULD BE A RESULT OF INSULATION DEGRADATION LEAD CHATTER. A FEW AP IN THE STRIP AND CAPTURE IS UNKNOWN. HCP IN AGREEMENT AND WILL BRING TO THE PROVIDER. FIRST ATRIAL PACING LEAD IMPEDANCE OUT OF RANGE WAS FROM SEP 25, 2022. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: CUSTOMER PROVIDED PATIENT DETAILS. IN ADDITION, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS SPECULATING THAT THE NOISE WAS LEAD INSULATION DEGRADATION LEAD CHATTER. I AM STILL NOT SURE IF THE LEAD WAS REMOVED. I ASKED THE FIELD REPRESENTATIVE FOR RESOLUTION. LSS IS LEAD SAFETY SWITCH. THAT IS WHEN THE LEAD IMPEDANCE IS OUT OF RANGE IT SWITCHES FROM BIPOLAR TO UNIPOLAR SENSING. TS REVIEWED THE PRESENTING ELECTROGRAM (EGM). ON THE REPORTS WE COULD SEE WHAT THE EGM NORMALLY LOOKS LIKE WHEN THERE AREN'T ANY EPISODES STORED IN THE DEVICE. AP MEANS ATRIAL PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237666 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4015

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female