BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6049233 · Received October 21, 2016

    Report

    Report Number
    2938836-2016-13146
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A REMOTE TRANSMISSION SHOWED NOISE EPISODES ON THE ATRIAL CHANNEL. A SLIGHT INCREASE IN ATRIAL THRESHOLD AND LOWER OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS WERE OBSERVED. NO FURTHER ACTION WAS RECOMMENDED OR COMPLETED. THE PHYSICIAN DECIDED TO ONLY CONTINUE TO MONITOR THE PATIENT USING THE REMOTE CARE. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697983 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1688T/52 0002159514

    Patients

    Seq Age Sex Outcome Treatment
    1