BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIGHT VENTRICULAR ICD LEAD

    MDR report key: 17297613 · Received July 10, 2023

    Report

    Report Number
    MW5119244
    Event Type
    Other
    Date Received
    July 10, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 1, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MRN# (B)(6) WAS NOTED TO HAVE EVIDENCE FOR RIGHT VENTRICULAR LEAD FAILURE AND WAS DEEMED APPROPRIATE FOR OPERATIVE INTERVENTION FOR RIGHT VENTRICULAR LEAD REPLACEMENT AND DUAL-CHAMBER DEFIBRILLATOR GENERATOR CHANGE. REFERENCE REPORT: MW5119245.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241161 RIGHT VENTRICULAR ICD LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male DUAL-CHAMBER DEFIBRILLATOR GENERATOR.