BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 20362052 · Received October 2, 2024

    Report

    Report Number
    MW5160534
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    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 VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING. THE LEAD SHOWED STABLE IMPEDANCES. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DISCLAIMER STATEMENT: 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
    2602424 CAPSURE SP NOVUS LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown