BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 17525434 · Received August 12, 2023

    Report

    Report Number
    MW5132375
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    July 27, 2021
    Report Date
    October 18, 2021
    Manufacturer
    UNKNOWN
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    1 HIGH RATE NS ON (B)(6)2021. OVER SENSING NOTED ON LEAD. LEAD TRENDS WITHIN RANGE. NO OTHER OVER SENSING NOTED. DEVICE APPEARS TO BE CURRENTLY FUNCTIONING AS PROGRAMMED. FYI EMAIL SENT TO LOCAL MOT RCO. (B)(4). 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
    565244 LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY UNKNOWN 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown