BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT ATRIAL (RA) LEAD

    MDR report key: 20336593 · Received September 27, 2024

    Report

    Report Number
    MW5160326
    Event Type
    Injury
    Date Received
    September 27, 2024
    Report Date
    August 26, 2024
    Manufacturer
    SORIN CRM SAS
    Product Code
    NVN
    Adverse Event
    Yes
    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 WAS PART OF A SYSTEM REVISION DUE TO EROSION. REPORTEDLY, THE GENERATOR WAS EXPOSED IN THE PATIENT'S POCKET. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED. 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
    1870805 RIGHT ATRIAL (RA) LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN SORIN CRM SAS RF45D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown