BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 1955808 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00685
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS REVEALED THAT THE PROXIMAL COIL WAS FRACTURED AND THE LEAD BODY WAS BENT IN THE SUTURE SLEEVE AREA. THE LOCATION AND APPEARANCE OF THE LEAD BODY INDICATED THAT THE COIL FRACTURED OVER TIME DUE TO FATIGUE. AN ABRASION MARK WAS FOUND ON THE INSULATION AT 13.0 CM FROM THE CONNECTOR PIN.

    Description of Event or Problem · 1

    EXIT BLOCK AND LEAD FRACTURE WERE REPORTED. THE LEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL DX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1388K/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention