BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIGHT VENTRICULAR (RV) LEAD

    MDR report key: 22998993 · Received September 8, 2025

    Report

    Report Number
    MW5175783
    Event Type
    Other
    Date Received
    September 8, 2025
    Date of Event
    August 24, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    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 TO THE CLINIC VIA REMOTE MONITORING. UPON REVIEW, NONSUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) ALERT WAS OBSERVED DUE TO UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO AN INAPPROPRIATE SHOCK AFTER AN EPISODE OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR) WAS NOTED IN THE VENTRICULAR FIBRILLATION (VF) DETECTION ZONE. PROGRAMMING CHANGES WERE RECOMMENDED TO RESOLVE BOTH ANOMALIES. "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
    2049118 RIGHT VENTRICULAR (RV) LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK SE & CO. KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown