BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4191970 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04628
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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 FIELD COMPLAINT OF A HELIX DEPLOYMENT ANOMALY WAS CONFIRMED IN THE LABORATORY. AS RECEIVED, THE HELIX WAS FULLY EXTENDED TO WITHIN SPEC AND CLOGGED WITH BLOOD AND TISSUE. X RAY ANALYSIS REVEALED OVERTORQUE TO THE INNER COIL, CONSISTENT WITH THAT OF MULTIPLE ATTEMPTS TO DEPLOY THE HELIX. THIS MAY HAVE CAUSED THE SUBSEQUENT REPORTED ROTATION OF THE LEAD BODY. THE LEAD EXHIBITED NORMAL ELECTRICAL AND MECHANICAL CHARACTERISTICS. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD BODY WAS TORQUING AS HELIX WAS BEING DEPLOYED. THE LEAD WAS UNABLE TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29799 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR