BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4193596 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04174
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 18, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 IMPEDANCE AND HIGH THRESHOLD WAS NOT CONFIRMED IN THE ANALYSIS. A PARTIAL LEAD WAS RETURNED AND A CUT WAS FOUND AT 52CM FROM THE HELIX END CONSISTENT WITH THE DAMAGE FROM FIELD. THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD EXHIBITED HIGH THRESHOLD HIGH IMPEDANCE AND CAPTURE ANOMALY. THE LEAD ALSO DISLODGED BEFORE THE CASE ENDED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28290 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR