BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 8861605 · Received August 5, 2019

    Report

    Report Number
    2017865-2019-11832
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501996
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. UPON INTERROGATION IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LEAD NOISE. NO PROGRAMMING CHANGES WERE MADE. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653073 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/58 4358885 05414734501996

    Patients

    Seq Age Sex Outcome Treatment
    1