BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC LEAD

    MDR report key: 17525838 · Received August 12, 2023

    Report

    Report Number
    MW5132779
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 1, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    T-WAVE OVERSENSING NOTED ON STORED VENTRICULAR EGMS. NO INAPPROPRIATE THERAPIES HAVE BEEN DELIVERED SINCE LAST CLEAR ON (B)(6) 2022, SEE R-WAVE AMPLITUDE TREND FOR VARIATION IN MEASUREMENTS. PROGRAMMED RV PACE / SENSE POLARITY IS BIPOLAR / BIPOLAR WITH SENSITIVITY AL 0.30 MV FYI LO REP. (B)(4). 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
    869208 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. 30-1815 AND 30-1815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown