BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 2083834 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-03010
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 11, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED A CAPTURE THRESHOLD OF 3.75 V, 0.4 MS. IN SEPTEMBER 2010 THE VENTRICULAR CAPTURE THRESHOLD WAS 0.5 V, 0.4 MS. AFTER INCREASING THE PULSE WIDTH TO 1.0 MS, RIGHT VENTRICULAR CAPTURE WAS OBTAINED AT 2.25 V. THE LEAD WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR