BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 4143680 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05754
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 28, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. FINAL ANALYSIS SHOWED THAT THE INSIDE INNER COIL WAS CLOGGED WITH BLOOD, WHICH WAS CAUSING STYLET INSERTION DIFFICULTY. ELECTRICAL TESTS OF THE LEAD FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS UNDERSENSING. THE LEAD WAS REPOSITIONED, BUT THE STYLET WOULD NOT FULLY INSERT INTO THE LUMEN OF THE LEAD. THE LEAD WAS ULTIMATELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31524 TENDRIL STS DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention