BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3925362 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08897
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    August 30, 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 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. A PARTIAL LEAD MEASURING 53 CM FROM THE PROXIMAL END WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED REVEALED SHORT CIRCUIT DOE TO OVERTORQUED INNER COIL INSIDE THE CONNECTOR PORTION. THIS MAY HAVE CAUSED THE REPORTED CAPTURE ANOMALIES. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH THRESHOLD AND EXIT BLOCK IN THE ATRIAL CHANNEL. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38239 TENDRIL STS DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention