BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA LEAD

    MDR report key: 17712867 · Received September 7, 2023

    Report

    Report Number
    MW5145401
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Report Date
    July 26, 2023
    Manufacturer
    SORIN CRM SAS
    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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW AMPLITUDES. TECHNICAL SERVICES (TS) REVIEWED THE ATRIAL TACHY RESPONSE (ATR) EVENTS AND NOTED THAT THERE WERE NOISY SIGNALS. THIS LEAD REMAINS IN USE. 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
    143714 RA LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN SORIN CRM SAS R45

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown