BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 23244694 · Received October 8, 2025

    Report

    Report Number
    2182208-2025-05612
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    October 28, 2023
    Report Date
    October 8, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/22 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LEAD EXTRACTION IN CHILDREN AND YOUNG ADULTS: WHEN IS THE BEST TIME FOR LEAD/SYSTEM REPLACEMENT? PEDIATRIC CARDIOLOGY. 2025. 46:61¿71. DOI: 10.1007/S00246-023-03320-9. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING TRANSVENOUS LEAD EXTRACTION (TLE) IN CHILDREN AND YOUNG ADULTS. PATIENTS IN THIS STUDY WERE ALL IMPLANTED WITH THEIR DEVICE SYSTEMS UNDER THE AGE OF NINETEEN AND EITHER HAD TLE UNDER THE AGE OF NINETEEN OR OVER THE AGE OF NINETEEN. THE AUTHORS DESCRIBED THE INDICATIONS FOR TLE WERE DUE TO SYSTEMIC INFECTIONS, POCKET INFECTIONS, MECHANICAL LEAD FAILURE (ELECTRICAL FAILURE), OR LEAD DYSFUNCTION (EXIT/ENTRY BLOCK, DISLODGEMENT, EXTRACARDIAC PACING). TECHNICAL COMPLICATIONS RELATED TO TLE INCLUDED UNKNOWN UNEXPECTED TECHNICAL PROBLEMS, OCCLUSION OF THE ACCESS VEIN, LEAD-ON-LEAD SCARRING, OR LEAD BREAK DURING EXPLANT. ADVERSE EVENTS RELATED TO TLE INCLUDED HEMOPERICARDIUM, SEVERE TRICUSPID VALVE DAMAGE, AND PATIENTS WHICH REQUIRED RESCUE CARDIAC SURGERY. THE STATUS OF THE LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565549 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Required Intervention| H| L UNKNOWN COMPETITOR CIED.