BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC LEAD

    MDR report key: 22500205 · Received July 14, 2025

    Report

    Report Number
    2182208-2025-03393
    Event Type
    Death
    Date Received
    July 14, 2025
    Date of Event
    February 7, 2024
    Report Date
    July 14, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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/68 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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: ASSESSING CARDIAC RESYNCHRONIZATION THERAPY RESPONSE IN HEART FAILURE PATIENTS: A COMPARATIVE ANALYSIS OF EFFICACY AND OUTCOMES BETWEEN TRANSVENOUS AND EPICARDIAL LEADS. MONALDI ARCHIVES FOR CHEST DISEASE. 2025; 95:2845. DOI: 10.4081/MONALDI.2024.2845. 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 CARDIAC RESYNCHRONIZATION THERAPY RESPONSE IN HEART FAILURE PATIENTS. THE AUTHORS DESCRIBED PATIENT DEATHS; CAUSES OF DEATH INCLUDED INFECTIONS, POST-OPERATIVE COMPLICATIONS, CHRONIC KIDNEY FAILURE, LIVER FAILURE, AND OTHER UNKNOWN CAUSES DESCRIBED AS CARDIOVASCULAR OR ALL-CAUSE MORTALITY. PATIENTS WERE IMPLANTED WITH TRANSVENOUS LEADS UNLESS IT WAS NOT FEASIBLE, THEN THEY WERE IMPLANTED WITH AN EPICARDIAL LEAD. EPICARDIAL LEAD PLACEMENT OCCURRED DUE TO TRANSVENOUS LEAD DISLODGMENT, DEVICE ENDOCARDITIS WITH LEAD EXTRACTION, HIGH THRESHOLDS, SUBCLAVIAN VEIN OCCLUSION/STENOSIS, OR CORONARY SINUS DISSECTION. THERE WERE PATIENTS WHO EXPERIENCED PNEUMOTHORAX POST-OPERATIVELY AND OTHER COMPLICATIONS THAT OCCURRED IN THE FOLLOW UP PERIOD WHICH INCLUDED TWIDDLER'S SYNDROME, HEART FAILURE HOSPITALIZATIONS, DEVICE ENDOCARDITIS, AND LEAD FRACTURE. THE STATUS OF THE DEVICES AND 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
    399920 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death UNKNOWN COMPETITOR CRT-D AND LEAD