BEUDAMED
    FDA Adverse Event Other Summary report: N

    RA LEAD

    MDR report key: 17400394 · Received July 25, 2023

    Report

    Report Number
    MW5120111
    Event Type
    Other
    Date Received
    July 25, 2023
    Report Date
    May 26, 2023
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAI (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD REMAINS IN SERVICE. 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
    2317204 RA LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN BIOTRONIK, INC. 350974 29241524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown