BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACING LEAD

    MDR report key: 23707719 · Received December 3, 2025

    Report

    Report Number
    1035166-2025-00061
    Event Type
    Injury
    Date Received
    December 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO LEAD WAS PROVIDED FOR ANALYSIS. THE LEAD WAS EXPLANTED DUE TO INFECTION, AND A NEW SYSTEM WAS IMPLANTED. THERE WAS NO ADDITIONAL PATIENT EFFECTS REPORTED. THIS EVENT WAS REPORTED THROUGH FDA'S VOLUNTARY MEDWATCH PROGRAM MDR REPORT#: MW5177418. NO IMPLANT DATE, EXPLANT DATE OR CUSTOMER DETAILS WERE NOT PROVIDED; THEREFORE, NO ADDITIONAL INFORMATION RELATED TO THIS PATIENT OR EVENT COULD NOT BE REQUESTED. THE SERIAL NUMBER NOR LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS, AND QA FINAL INSPECTIONS INCLUDING STERILIZATION BEFORE SHIPPING TO THE CUSTOMER. THE LEAD IS NO LONGER MANUFACTURED BY OSCOR. NO CORRECTIONS OR CORRECTIVE ACTIONS WILL BE TAKEN. THE COMPLAINT IS NON-VERIFIABLE AS THE LEAD WAS NOT RETURNED FOR EVALUATION. 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 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, 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

    THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) RECEIVED A MEDICAL DEVICE REPORT CONCERNING YOUR PRODUCT. ON 22-SEP-2025, IT WAS REPORTED TO THE FDA, THIS IMPLANTABLE LEAD WAS EXPLANTED DUE TO INFECTION. A NEW SYSTEM WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863709 PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. RU61W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization