BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC CRT

    MDR report key: 22382888 · Received July 2, 2025

    Report

    Report Number
    2182208-2025-03192
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    April 17, 2024
    Report Date
    July 2, 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: EFFECT OF ADAPTIVE CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WITH PACEMAKER DEPENDENCY. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2024. 67:1571¿1577. DOI: 10.1007/S10840-024-01776-0BY 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 THE CLINICAL IMPACT OF AN ADAPTIVE CARDIAC RESYNCHRONIZATION THERAPY (ACRT) ALGORITHM. PATIENTS WERE IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE EITHER WITH OR WITHOUT THE ALGORITHM. THE AUTHORS DESCRIBED PATIENT DEATHS IN BOTH GROUPS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DEFINED AS ALL-CAUSE. THERE WERE PATIENTS WHO EXPERIENCED HEART FAILURE (HF) HOSPITALIZATIONS WHICH INCLUDED UNEXPLAINED SYNCOPE. THE PATIENTS WITH THE USE OF THE ACRT ALGORITHM HAD LESS ALL-CAUSE DEATH AND/OR HOSPITALIZATION RATES FOR HF THAN THE GROUP WITHOUT. THERE IS NO ALLEGATION OF DEVICE-DEATH OR HF HOSPITALIZATION RELATEDNESS INDICATED IN THE ARTICLE. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12061 MEDTRONIC CRT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. MDT-CRT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L UNKNOWN COMPETITOR LEADS