BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC CRT-D

    MDR report key: 22523296 · Received July 16, 2025

    Report

    Report Number
    2182208-2025-03489
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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: PRESENCE OF INEFFECTIVE CARDIAC RESYNCHRONIZATION THERAPY PACING PROVIDES INSIGHTS INTO HIDDEN CAUSES AND THERAPEUTIC TARGETS OF NONRESPONDER. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2025; 36:925¿934. DOI: 10.1111/JCE.16605. 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 EFFECTIVE CARDIAC RESYNCHRONIZATION THERAPY (CRT) RESPONSE. THE AUTHORS DESCRIBED PATIENT DEATHS IN BOTH GROUPS OF PACING PERCENTAGE CRT RESPONSE; THERE WERE TWO PATIENTS IN EACH GROUP THAT DIED DUE TO SUDDEN CARDIAC DEATH AND OTHER UNKNOWN CAUSES OF DEATH. THERE WERE PATIENTS WHO EXPERIENCED HEART FAILURE HOSPITALIZATIONS. THERE WERE LEFT VENTRICULAR (LV) LEADS WHICH EXHIBITED LOSS OF CAPTURE WITH ONE DISLODGEMENT WHICH WAS REIMPLANTED, AND THE OTHER LEADS WERE REPROGRAMMED. 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
    554450 MEDTRONIC CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. MDT-CRT-D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization UNKNOWN COMPETITOR LEAD