BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 8903850 · Received August 16, 2019

    Report

    Report Number
    2017865-2019-12496
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 2, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502894
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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'S RIGHT VENTRICULAR LEAD HAD NOISE. MORE INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT RIGHT VENTRICULAR LEAD NOISE WAS NOTED AGAIN AND WAS REPRODUCIBLE WITH ISOMETRICS. NO INTERVENTION WAS PERFORMED AS THE PHYSICIAN OPTED TO CONTINUE MONITORING THE PATIENT. THE PATIENT'S CONDITION WAS ASYMPTOMATIC THROUGHOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697056 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/58 3626417 05414734502894

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR