BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 4071449 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-07841
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    October 3, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 FORWARD. EVAL DESCRIPTION: FINAL ANALYSIS FOUND AN ELECTRICAL SHORT DUE TO OVERTORQUING OF THE INNER COIL IN THE CONNECTOR REGION. THIS COULD CONTRIBUTE TO THE PROBLEM DETECTED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE ATRIAL LEAD EXHIBITED LOW LEAD IMPEDANCE AND LOSS OF SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36433 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention