BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT VENTRICULAR LEAD

    MDR report key: 19860468 · Received July 26, 2024

    Report

    Report Number
    MW5157777
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Report Date
    June 26, 2024
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD REQUIRED MULTIPLE DELIVERY ATTEMPTS. THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    282016 RIGHT VENTRICULAR LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN BIOTRONIK, INC. S 60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown