BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 17509312 · Received August 11, 2023

    Report

    Report Number
    MW5122917
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    February 8, 2023
    Manufacturer
    BIOTRONIK
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2022 16:10:33 RV LEAD INTEGRITY WARNING: 2 OR MORE HIGH RATE-NS EPISODES LESS THAN 220 MS. SENSING INTEGRITY COUNTER GREATER THAN OR EQUAL TO 30 IN 3 DAYS. (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
    1355228 RV LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK 359073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown