BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 10715658 · Received October 21, 2020

    Report

    Report Number
    2017865-2020-15957
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    October 19, 2020
    Report Date
    October 29, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTED FRACTURE ON THE RIGHT ATRIAL LEAD. THE LEAD WAS CAPPED AND REPLACED ON 10/19/2020. THE PATIENT WAS STABLE.

    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 RIGHT ATRIAL (RA) LEAD WAS NOTED WITH NOISE. THE LEAD NOISE CAUSED OVERSENSING EPISODES. THE LEAD WAS CAPPED AND REPLACED ON 10/19/2020. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175649 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1488TC/52 0002399073

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention