BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUTRINO¿ NXT VR

    MDR report key: 23386203 · Received October 24, 2025

    Report

    Report Number
    2017865-2025-1003380
    Event Type
    Death
    Date Received
    October 24, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05415067049438
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE RETRACT 2017865-2025-1003380, AS ADDITIONAL INFORMATION REVEALED THAT THE PATIENT'S DEATH WAS DUE TO AGE RELATED ILLNESS AND THERE WAS NO ALLEGATION OF MALFUNCTION ON THE PATIENT'S DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE VENTRICULAR TACHYCARDIA (VT) EPISODES IN WHICH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PROVIDED APPROPRIATE SHOCKS, HOWEVER, THEY WERE NOT ABLE TO CONVERT ALL THE EPISODES, AND THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL SUGGESTING THE DEATH WAS RELATED TO ANY ABBOTT PRODUCTS OR PROCEDURES. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790381 NEUTRINO¿ NXT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDVRA600T S000099405 05415067049438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death