BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 4121382 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07019
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 19, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE REPORTED LEAD WAS RETURNED FOR HIGH IMPEDANCE AND CLOGGED HELIX. THE HIGH LEAD PACING IMPEDANCE COULD NOT BE CONFIRMED. ANALYSIS WAS NORMAL. NO ANOMALY WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH PACING IMPEDANCE AND HELIX WOULD NOT EXTEND OR EXTRACT. THE LEAD WAS NOT IMPLANTED AND SENT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33097 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE, NVN NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR