BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT NGQ DEVICE

    MDR report key: 18422829 · Received December 30, 2023

    Report

    Report Number
    2017865-2023-95746
    Event Type
    Malfunction
    Date Received
    December 30, 2023
    Report Date
    March 25, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAILED TO BE INTERROGATED IN CLINIC. NO INTERVENTION WAS PERFORMED. THE PATIENT'S STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286347 ABBOTT NGQ DEVICE NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDDRA500Q

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown