BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACING LEAD

    MDR report key: 23426023 · Received October 30, 2025

    Report

    Report Number
    1035166-2025-00051
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 30, 2025
    Manufacturer
    INTEGER
    Product Code
    DTB
    PMA / PMN Number
    K850623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS PROVIDED FOR ANALYSIS, NOR WERE ANY PICTURES PROVIDED BY THE CUSTOMER. IT WAS REPORTED THAT THE LEAD WAS IMPLANTED ON (B)(6) 1998 AND EXPLANTED ON (B)(6) 2025 DUE TO INFECTION. NO PATIENT HARM REPORTED. NO DEVICE PROBLEM REPORTED. PRODUCT NOT RETURNING. BASED UPON THE IMPLANT DATE OF THIS LEAD (1998), THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL IS BEYOND INTEGER'S RECORD RETENTION PERIOD. INSPECTION PROCEDURES REQUIRE ANY INTEGER PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. NO PRODUCT WAS RETURNED TO INTEGER FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, INTEGER IS UNABLE TO DETERMINE THE EXACT CAUSE OF 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. 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 HAVE NOT 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

    THIS EVENT IS RELATED TO 4440/813667 WHICH WAS IMPLANT ON (B)(6) 1998 AND EXPLANTED ON (B)(6) 2025 DUE TO INFECTION. THERE IS NO REPORT OF A DEVICE PROBLEM. PRODUCT NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542414 PERMANENT PACING LEAD PERMANENT PACING LEAD DTB INTEGER 4440

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| R