BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINOX SMART

    MDR report key: 22214741 · Received June 16, 2025

    Report

    Report Number
    MW5171542
    Event Type
    Other
    Date Received
    June 16, 2025
    Date of Event
    June 10, 2025
    Report Date
    June 12, 2025
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC VIA DATA TRANSMISSION FOR THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. UPON REVIEW, MULTIPLE EPISODES OF RIGHT VENTRICULAR OVSERSENSING WERE OBSERVED ON THEIR RIGHT VENTRICULAR LEAD. IT WAS SUSPECTED THAT THE LEAD WAS DAMAGED. THE LEAD WAS REPORTED TO BE IMPLANTED ON (B)(6) 2010. THE PATIENT¿S CONDITION WAS STABLE. "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
    1008694 LINOX SMART PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown