BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA LEAD

    MDR report key: 21655065 · Received March 20, 2025

    Report

    Report Number
    MW5167906
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Report Date
    January 31, 2025
    Manufacturer
    ELA MEDICAL / SORIN CRM SAS
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD RWAVE (FFRW) OVER-SENSING ON STORED ELECTROGRAMS (EGM). THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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
    1203069 RA LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN ELA MEDICAL / SORIN CRM SAS P2P752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown