BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC CRT-D

    MDR report key: 20024601 · Received August 22, 2024

    Report

    Report Number
    2182208-2024-03533
    Event Type
    Death
    Date Received
    August 22, 2024
    Date of Event
    December 7, 2023
    Report Date
    August 20, 2024
    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. 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: TWO-YEAR OUTCOMES OF PRIMARY PROPHYLACTIC USE OF DEFIBRILLATORS FOR ISCHEMIC AND NON-ISCHEMIC CARDIOMYOPATHY PROPENSITY SCORE-MATCHED ANALYSIS FROM THE NIPPON STORM STUDY. CIRCULATION JOURNAL. 2024; 88: 1107 ¿ 1114. DOI: 10.1253/CIRCJ.CJ-23-0613. 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 EFFECTIVENESS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN PATIENTS WITH NON-ISCHEMIC CARDIO MYOPATHY (NICM) OR ISCHEMIC CARDIOMYOPATHY (ICM). THE AUTHORS DESCRIBED PATIENT DEATHS; THE DEATHS WERE CLASSIFIED AS CARDIOVASCULAR, NON-CARDIOVASCULAR DEATH, OR ALL-CAUSE. SOME OF THE CAUSES OF CARDIOVASCULAR DEATH WERE WORSENING HEART FAILURE; THE OTHER CAUSES OF DEATH WERE UNKNOWN. THERE IS NO ALLEGATION OF DEVICE-DEATH RELATEDNESS INDICATED IN THE ARTICLE; HOWEVER, THE CAUSE OF DEATH AND DEVICE-RELATEDNESS HAS BEEN REQUESTED. THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPY DUE TO DETECTION OF ARRHYTHMIAS. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358252 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 Death UNKNOWN COMPETITOR LEADS