BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ICD

    MDR report key: 23877765 · Received December 23, 2025

    Report

    Report Number
    2182208-2025-13794
    Event Type
    Death
    Date Received
    December 23, 2025
    Date of Event
    January 1, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/60 YEARS OLD. 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: REDUCING UNNECESSARY IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR THERAPY WITH ENHANCED PROGRAMMING: LONG-TERM OUTCOMES OF THE ENHANCED-ICD STUDY. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2025. 36:2861¿2869. DOI: 10.1111/JCE.70060. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROGRAMMING. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DEFINED AS ALL-CAUSE. NONE OF THE DEATHS WERE ATTRIBUTED TO ARRHYTHMIA. THERE WERE PATIENTS WHO EXPERIENCED ARRHYTHMIA- OR SHOCK-RELATED HOSPITALIZATIONS, SYNCOPAL EPISODES, AND INAPPROPRIATE SHOCKS OR ANTI-TACHYCARDIA PACING (ATP). ONE PATIENT'S HOSPITALIZATION AND SYNCOPAL EPISODE WAS CAUSED BY ATRIAL FLUTTER WITH RAPID VENTRICULAR RESPONSE. THERE WERE OTHER PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPY DUE TO SUPRA VENTRICULAR TACHYCARDIA (SVT). DEVICES WERE REPROGRAMMED OR REVISED. THE STATUS OF THE ICDS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918665 MEDTRONIC ICD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death UNKNOWN MEDTRONIC LEADS.