BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6949 SPRINT FIDELIS

    MDR report key: 17534133 · Received August 12, 2023

    Report

    Report Number
    MW5141036
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    February 2, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 01/25/2012 FROM SALES REP. THE RV LEAD IS FRACTURED. NO PHYSICIAN OR HOSPITAL KNOWN. 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
    1216729 6949 SPRINT FIDELIS PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown