BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT VENTRICULAR LEAD

    MDR report key: 17774030 · Received September 18, 2023

    Report

    Report Number
    MW5145838
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Report Date
    September 1, 2023
    Manufacturer
    CARDIO PACE MEDICAL INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED NOISY SIGNALS AND A LOW, OUT OF RANGE IMPEDANCE. ALSO, RV INTRINSIC AMPLITUDE WAS OUT OF RANGE. THE RV LEAD REMAINS IN SERVICE AT THIS TIME. 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
    2061819 RIGHT VENTRICULAR LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY CARDIO PACE MEDICAL INC. AT-443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown