BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2014103 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01450
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 20, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    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. (B)(6). FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND MEDICAL ADHESIVE ON THE RING ELECTRODE, CAUSING THE LEAD IMPEDANCE AND CAPTURE ANOMALIES.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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