BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1955751 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00786
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF CONSTANT CHEST PAIN. AN ECHOCARDIOGRAM AND CHEST X-RAY FOUND THE LEAD IN GOOD POSITION AND NO EFFUSION OR PERFORATION. ALL MEASURED VALUES WERE NORMAL. WHEN THE POCKET WAS OPENED A -KINK- WAS NOTED IN THE COIL. THE PHYSICIAN TRIED TO PASS A STYLET THROUGH THE LEAD, BUT IT ENDED UP COMING THROUGH THE INSULATION, SO THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention