BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR ICD, US

    MDR report key: 24492128 · Received March 2, 2026

    Report

    Report Number
    2017865-2026-04336
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    August 21, 2025
    Report Date
    March 24, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734507974
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTES THE PATIENT WAS ASYMPTOMATIC. NO CHANGES WERE MADE TO FULLY ADDRESS THE UNDERSENSING AS THE OBSERVATION WAS RARE, BUT SOME PROGRAMMING CHANGES WERE MADE TO TACHYCARDIA ZONES. THERE WERE NO OTHER COMPLAINTS ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS MONITORED. THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREMATURE VENTRICULAR CONTRACTIONS (PVCS) FOLLOWED BY R WAVES UNDERSENSED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WERE OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585233 FORTIFY ASSURA VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD1357-40Q A000100984 05414734507974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male OPTISURE MRI