BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 1896550 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04905
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 29, 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 Location
    MD
    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 LEAD EXHIBITED UNDERSENSING. THE SENSITIVITY WAS SET TO 1.5 MV BUT THE R WAVES WERE COMING IN AT LESS THAN 1.0 MV. SENSITIVITY WAS REPROGRAMMED TO 0.5 MV FOR A 2:1 SAFETY MARGIN. A LEAD REVISION WAS PLANNED.

    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 1388TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR