BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1073293 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02092
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 8, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LABORATORY TESTING OF THE DEVICE LISTED IN THE REPORT(S) INCLUDING: A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED. AN IDENTIFICATION OF THE FAILURE MODE(S), AND/OR MECHANISM(S), AND THE ASSOCIATED COMPONENT(S) INVOLVED. ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LABORATORY TEST RESULTS. THE LEAD HAS NOT BEEN RETURNED, SO ANALYSIS CAN NOT BE COMPLETED.

    Description of Event or Problem · 1

    DURING A PULSE GENERATOR UPGRADE, THE RIGHT VENTRICULAR LEAD WAS CONNECTED AND THE PATIENT WENT ASYSTOLIC WITH NO RIGHT VENTRICULAR OR LEFT VENTRICULAR PACING. THE LEADS WERE NORMAL PER THE ANALYZER. THE LEFT VENTRICULAR LEAD WAS PLUGGED INTO THE RIGHT VENTRICULAR PORT AND NORMAL PACING WAS SEEN, THE RIGHT VENTRICULAR LEAD WAS SUSPECTED AS THE PROBLEM. THE LEAD IMPEDANCE WAS GREATER THAN 2500 OHMS. THE LEAD WAS SUBSEQUENTLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention