BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT ATRIAL (RA) LEAD HAD

    MDR report key: 22214855 · Received June 16, 2025

    Report

    Report Number
    MW5171548
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Report Date
    May 27, 2025
    Manufacturer
    SORIN BIOMEDICAL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD HAD EXHIBITED INFECTION. A REVISION WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED, WHILE THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE CAPPED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL 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
    1008698 RIGHT ATRIAL (RA) LEAD HAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN SORIN BIOMEDICAL VEGA R52

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown