BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 4193558 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05517
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 29, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL DESCRIPTION: THE REPORTED FIELD EVENT OF HIGH THRESHOLD AND SENSING ANOMALY WAS NOT CONFIRMED. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. ANALYSIS FOUND HELIX CLOGGED WITH DRIED BODY FLUID PREVENTING THE HELIX FROM EXTENDING. AFTER CLEANING, HELIX COULD EXTEND AND RETRACT WITH SOME DIFFICULTY DUE TO DETERMINATION OF THE INNERCOIL CAUSED BY OVER TORQUING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD EXHIBITED CAPTURE AND SENSING ANOMALIES HIGH PACING THRESHOLD AND A HELIX ANOMALY. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33829 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR