BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 21961488 · Received May 5, 2025

    Report

    Report Number
    2182208-2025-02190
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    October 11, 2024
    Report Date
    May 5, 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/63 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: RIGHT VENTRICULAR SYSTOLIC PRESSURE PREDICTS OUTCOMES IN PATIENTS WITH CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS. POLISH HEART JOURNAL. 2024. 82 (12): 1239-1246. DOI: 10.33963/V.PHJ.102981 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 ASSOCIATION EXISTS BETWEEN RIGHT VENTRICULAR (RV) DYSFUNCTION AND ANTIARRHYTHMIC THERAPIES OR ALL-CAUSE MORTALITY IN REMOTELY MONITORED PATIENTS WITH HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D). THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DEFINED AS ALL-CAUSE. THERE WERE PATIENTS WHO EXPERIENCED MYOCARDIAL INFARCTIONS, STROKES, AND INAPPROPRIATE THERAPY WHICH INCLUDED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS. CAUSES OF INAPPROPRIATE THERAPY INCLUDED DETECTION OF SUPRA VENTRICULAR TACHYCARDIA (SVT), ATRIAL FIBRILLATION (AF), ATRIAL FLUTTER, AND T-WAVE OVERSENSING (TWOS). 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
    1831355 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| L UNKNOWN COMPETITOR CRT-D AND LEADS