BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4193299 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04391
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 24, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF LOW LEAD IMPEDANCE WAS CONFIRMED AND WAS DUE TO AN ELECTRICAL SHORT WITHIN THE LEAD. THE SHORT WAS CAUSED BY DAMAGE TO THE INNER INSULATION FROM OVERTORQUE OF THE INNER COIL DURING THE SURGICAL PROCEDURE. THE DAMAGE IS ALSO CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NO SENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD EXHIBITED NO SENSING AND LOW LEAD IMPEDANCE. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31204 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1