BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 17471343 · Received August 4, 2023

    Report

    Report Number
    MW5120676
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Report Date
    August 1, 2023
    Manufacturer
    ST. JUDE/ABBOTT MEDICAL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEY KEEP GETTING AN AMBER/AMBULANCE ALERT TONE COMING FROM THE ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) EVERY 4 HOURS, IT COULD BE A POSSIBLE LEAD INTEGRITY WARNING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695629 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE/ABBOTT MEDICAL LDA210Q-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR).