BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT NGQ DEVICE

    MDR report key: 22302286 · Received June 20, 2025

    Report

    Report Number
    2017865-2025-87883
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A LITERATURE ARTICLE RECEIVED NOTES THAT A PATIENT WITH AN ABBOTT LEGACY DUAL-CHAMBER DEVICE EXHIBITED INAPPROPRIATE MODE SWITCH EPISODE DUE TO COMPETITIVE ATRIAL PACING (CAP) INDUCED ATRIAL FIBRILLATION, AND INAPPROPRIATE MODE SWITCH EPISODES DUE TO SUSTAINED AND NON-SUSTAINED CAP AND FAR-FIELD R-WAVE OVERSENSING NOTED ON BOTH ABBOTT LEGACY DUAL-CHAMBER DEVICES AND GALLANT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669687 ABBOTT NGQ DEVICE No Match NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NGQ DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown