BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM LEADS?

    MDR report key: 17488928 · Received August 9, 2023

    Report

    Report Number
    MW5121627
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    November 15, 2022
    Report Date
    December 1, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    RV LIA TRIGGERED (B)(6) 2022, FOR HR-NS AND SICS. MANY SHORT INTERVALS ARE RELATED TO DOUBLE COUNTING OF FAST WIDE COMPLEX VENTRICULAR RHYTHMS. NON SUSTAINED EPISODES HAVE A FEW BEATS OF APPARENT OVERSENSING UNRELATED TO PHYSIOLOGIC ACTIVITY. SOME DOUBLE COUNTING OF WIDE COMPLEX ARRHYTHMIAS WERE NOTED ON THE STORED EPISODES FROM (B)(6) 2022. 86 V-VS SINCE (B)(6) 2022. (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
    2013961 RIATA ST OPTIM LEADS? IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL 7021-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown