BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 11810036 · Received May 11, 2021

    Report

    Report Number
    2017865-2021-17880
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501996
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-17878. IT WAS REPORTED THAT THERE WAS LEAD NOISE ON BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS, WITH THE RIGHT ATRIAL LEAD OVER-SENSING THE NOISE. THE RIGHT ATRIAL LEAD SENSING ALSO HAD A DECREASE IN P-WAVE AMPLITUDES, AND THE RIGHT VENTRICULAR LEAD HAD AN INCREASE IN CAPTURE THRESHOLD SEEN. BOTH LEADS WERE CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705433 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/58 3109702 05414734501996

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention