BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA LEAD

    MDR report key: 18877382 · Received March 11, 2024

    Report

    Report Number
    MW5152589
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Report Date
    January 30, 2024
    Manufacturer
    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

    RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING, INAPPROPRIATE PACING AND IMPEDANCE WARNING. RIGHT VENTRICULAR (RV) LEAD EXHIBITED IMPEDANCE WARNING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT: MW5152590.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957090 RA LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN SORIN CRM SAS P758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown