BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACING LEAD

    MDR report key: 19140559 · Received April 18, 2024

    Report

    Report Number
    1035166-2024-00033
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    August 28, 2024
    Report Date
    May 20, 2024
    Manufacturer
    OSCOR.INC
    Product Code
    DTB
    PMA / PMN Number
    K964107
    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 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.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS PROVIDED FOR ANALYSIS. THE LEAD WAS CAPPED ON (B)(6) 2024 AND NEW DEVICE WAS IMPLANTED. THE DEVICE WAS IN SERVICE FOR APPROXIMATELY 25 YEARS, 8 MONTHS BEFORE BEING CAPPED ON (B)(6) 2024. THERE WAS NO ADVERSE EVENT WITH THE PATIENT. BASED UPON THE IMPLANT DATE OF THIS LEAD (1998), 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. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. 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. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. BASED ON THIS INFORMATION, A CAPA IS NOT REQUIRED. OSCOR WILL CONTINUE TO MONITOR THIS PRODUCT FOR COMPLAINT TRENDS. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NO FURTHER FOLLOW-UP IS REQUIRED. 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 LEAD RJ ZY44PJUSBV/(B)(6) WERE CAPPED ON (B)(6) 2024 DUE TO PRODUCT PERFORMANCE ISSUE.

    Description of Event or Problem · 0

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 17 MAY 2024, IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH CAPTURE THRESHOLD AND THE ENTIRE SYSTEM PRESENTED INFECTION. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036182 PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR.INC ZY 44 PJUSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown