BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA/RIATA ST

    MDR report key: 8468846 · Received April 1, 2019

    Report

    Report Number
    2938836-2019-02114
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING RIATA/RIATA ST WAS RELATED TO EXTERNALIZED CONDUCTORS, INCREASE PACING THRESHOLD AND IMPEDANCE, DECREASED R WAVE SENSING AND DECREASED HIGH VOLTAGE IMPEDANCE. DIAGNOSTIC IMAGING OR DURING DEVICE EXCHANGE CONFIRMED EXTERNALIZED CONDUCTORS. OUT OF RANGE ELECTRICAL MEASUREMENTS WERE NOTED DURING ROUTINE FOLLOW-UP. SPECIFIC PATIENT INFORMATION IS UNKNOWN. ROTEN, LAUREN (2018). COMPARISON OF LEAD FAILURE MANIFESTATION OF BIOTRONIK LINOX WITH ST. JUDE MEDICAL RIATA AND MEDTRONIC SPRINT FIDELIS LEAD. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. HTTPS://DOI.ORG/10.1007/S10840-018-0486-0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265098 RIATA/RIATA ST LWS ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1