BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACING LEAD

    MDR report key: 24173613 · Received January 24, 2026

    Report

    Report Number
    1035166-2025-00062
    Event Type
    Injury
    Date Received
    January 24, 2026
    Date of Event
    November 5, 2025
    Report Date
    January 24, 2026
    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

    NOTE: INITIAL SUBMISSION WAS SENT ON 12/22/2025. THE SUBMISSION PASSED BUT SHOULD HAVE FAILED DUE TO THE WRONG MFR NUMBER. FOLLOW UP 1 WAS SUBMITTED ON 01/13/2026, WHICH FAILED. THE OVERALL ISSUE WAS THE MFR # WAS LISTED AS AND SHOULD HAVE BEEN. THE TWO REPORTS HAVE BEEN CONSOLIDATED FOR A SINGLE SUBMISSION. NO DEVICE WAS RETURNED FOR ANALYSIS AND REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE WAS IN USE FOR TREATMENT. THE LEAD WAS IMPLANTED (B)(6) 2003 AND EXPLANTED (B)(6) 2025 AND WILL NOT BE RETURNED FOR ANALYSIS. THE CUSTOMER STATED THE DEVICE WAS EXPLANTED DUE TO INFECTION. 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. PER QUALITY ASSURANCE PROCEDURE. FINAL LABELING / PACKAGING INSPECTION OF ALL PRODUCTS: ALL LABELING AND PACKAGING WILL BE INSPECTED 100%. SHAKE THE OUTER TRAY BY HOLDING TAB OF OUTER TRAY TO ENSURE INNER TRAY IS LOOSE INSIDE THE OUTER TRAY. CHECK FOR FOREIGN MATERIAL AND TYVEK SEAL INTEGRITY. VERIFY THAT COLOR OF STERI-DOT CHANGED FROM BROWN TO GREEN. SEALED AREAS (TYVEK LID TO LIP OF TRAY) ARE CONTINUOUS AROUND ENTIRE PERIMETER OF TRAY. NO VOIDS, BREAKS, AND OR BUBBLES ALONG THE SEAL. THE ENTIRE SEAL SHOULD BE AT LEAST QUARTER INCH WIDE AND HAVE A FULL RIDGE. THE TYVEK PULL TAB MUST BE PROPERLY FOLDED INTO POSITION. EXAMINE THE SEAL AND BORDER FOR UNIFORMITY OF THE SEAL. CHECK FOR HOLES OR ANY OTHER DAMAGES THAT COULD VIOLATE STERILITY. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: THE LEADS ARE SUPPLIED STERILE. A STERILIZATION METHOD IS INDICATED ON THE PRODUCT LABEL. THE STERILITY IS COMPROMISED WHEN THE PACKAGE IS OPENED OR DAMAGED. INTEGER DOES NOT ASSUME ANY LIABILITY OR RESPONSIBILITY FOR STERILIZATION BY A THIRD PARTY. IN ADDITION, THE IFU LISTS INFECTION AS AN ADVERSE EFFECT: INFECTION, LEAD MAY REQUIRE SURGICAL REMOVAL. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY INTEGER. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTEGER WILL CONTINUE TO MONITOR THIS EVENT TYPE. 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. ON (B)(6) 2025 CUSTOMER REPORTED: 1. PATIENT INFORMATION: INITIALS: (B)(6), AGE: 80, SEX: M. 2. PATIENT OUTCOME: NO ADDITIONAL INFORMATION PROVIDED OTHER THAN THE INFECTION. 3. IMPLANT DATE: (B)(6) 2003 5. WAS THE DEVICE DISCARDED? UNKNOWN, GFE ATTEMPTED TO OBTAIN RETURN INFORMATION BUT PER FIELD REPRESENTATIVE'S REPLY, INFORMATION IS UNAVAILABLE PER CUSTOMER/ACCOUNT. 6. SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234981 PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB INTEGER 4036 C2-02347

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention