BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACING LEAD

    MDR report key: 23872464 · Received December 22, 2025

    Report

    Report Number
    1036166-2025-00062
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 22, 2025
    Manufacturer
    INTEGER
    Product Code
    DTB
    PMA / PMN Number
    K912867
    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. INTEGER 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 INTEGER 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, INTEGER, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, INTEGER, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    CALLED TO REPORT THAT DEVICE WAS EXPLANTED ON (B)(6) 2025 AND PLAN WAS TO EXTRACT LEADS ON (B)(6) 2025. DEVICE EXPLANTED DUE TO INFECTION. PATIENT OUTCOME: F08: HOSPITALIZATION OR PROLONGED HOSPITALIZATION, F1903: DEVICE EXPLANTATION. PRODUCT NOT RETURNING. AS REPORTED DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM. AS REPORTED PATIENT CODES: 9151: INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329840 PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB INTEGER 4036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention