BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2014002 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01398
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 10, 2011
    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 Location
    NH
    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 VENTRICULAR LEAD EXHIBITED UNDERSENSING DESPITE A SENSITIVITY OF 1.5 MV AND A R-WAVE MEASUREMENT OF 4 MV. THE VENTRICULAR AMPLITUDE TREND EXHIBITED A FLUCTUATION IN THE R-WAVE MEASUREMENTS FROM 3 MV TO GREATER THAN 12 MV.

    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 1488TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR