BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 11809809 · Received May 11, 2021

    Report

    Report Number
    2017865-2021-17861
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 11, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502887
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. INTERROGATION REVEALED THAT THE RIGHT ATRIAL LEAD EXHIBITED OW P-WAVE SENSING, INCREASING PACING IMPEDANCE, AND HIGH CAPTURE THRESHOLD. NO DEVICE INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705880 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 A000094275 05414734502887

    Patients

    Seq Age Sex Outcome Treatment
    1