BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 8824700 · Received July 24, 2019

    Report

    Report Number
    2017865-2019-11367
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 10, 2019
    Report Date
    October 2, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501859
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 A PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION REVEALED LOSS OF CAPTURE AND NOISE ON THE RIGHT VENTRICULAR LEAD. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE THROUGHOUT EVENT.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT THE LEAD WAS CAPPED AND REPLACED. PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617005 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/52 0002159997 05414734501859

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention