BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ICD

    MDR report key: 25043717 · Received April 30, 2026

    Report

    Report Number
    2182208-2026-25447
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    January 1, 2025
    Report Date
    April 30, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A 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: FUSION OR CONFUSION: AN ELECTRICAL ENIGMA. HEART RHYTHM CASE REPORTS. 2025. 11:1388¿1390) DOI: 10.1016/J.HRCR.2025.09.001 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE AUTHORS DESCRIBED A PATIENT WHO PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN AND THEN WAS ADMITTED AND DECONGESTED FOR HEART FAILURE WITH REDUCED EJECTION FRACTION (HFREF) DECOMPENSATION. IT WAS DETERMINED THE PATIENT WAS IN SLOW VENTRICULAR TACHYCARDIA (VT) IN WHICH THE RIGHT VENTRICULAR (RV) PACING FROM THE ICD SEEMED TO PROVOKE THIS RHYTHM. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101897 MEDTRONIC ICD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R UNKNOWN LEADS.