BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 19664978 · Received July 3, 2024

    Report

    Report Number
    1035166-2024-00076
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 27, 2024
    Report Date
    July 3, 2024
    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

    THE LEAD REMAINS ACTIVELY IMPLANTED AND IN SERVICE FOR APPROXIMATELY 23 YEARS, 11 MONTHS, SINCE THE EVENT DATE OF 27/MAY/2024. NO LEAD WAS RETURNED TO OSCOR INC. FOR EVALUATION, AS IT REMAINS IN ACTIVELY IMPLANTED; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. BASED UPON THE IMPLANT DATE OF THIS LEAD (B)(6) 2000, THE DEVICE HISTORY RECORD IS BEYOND OSCOR'S RECORD RETENTION PERIOD. 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. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THIS COMPLAINT IS NONVERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IN CONCLUSION, BASED ON THE INFORMATION AVAILABLE AT THIS TIME IT CANNOT BE CONFIRMED THAT THE PRODUCT FAILED TO MEET REQUIREMENTS. 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 THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE THAT RESULTED IN LEAD SAFETY SWITCH (LSS). TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND NOTED THAT THE IMPEDANCE WAS STABLE AND HAD AN ABRUPT DECREASE TO A LOW OUT OF RANGE VALUE AND RETURNED ITS BASELINE IMPEDANCE VALUE THEREAFTER. TS SUGGESTED FOLLOWING ACTIONS. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SERIAL NUMBER FOR THIS RA LEAD IS (B)(6), IMPLANT DATE IS (B)(6) 2000. THE LEAD REMAINS ACTIVELY IMPLANTED AND IN SERVICE FOR APPROXIMATELY 23 YEARS, 11 MONTHS SINCE THE EVENT DATE OF 27/MAY/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800211 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown