BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4193587 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04172
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 28, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 HELIX ANOMALY WAS CONFIRMED. MECHANICAL AND VISUAL ANALYSIS FOUND THAT THE HELIX COULD NOT BE EXTENDED. SILICONE, CARBON AND OXYGEN WERE FOUND ON THE HELIX AND THE CONTAMINATION OBSERVED WAS BELIEVED TO BE RESIDUES OF SILICON ADHESIVES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WAS TESTED PRIOR TO LEAD INSERTION DURING IMPLANT. THE HELIX COULD NOT BE ACTUATED PROPERLY. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28288 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1