BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 1896289 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04910
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 19, 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
    NE
    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 LOW IMPEDANCE, WITH MEASUREMENTS VARYING FROM 120 TO 420 OHMS. IT WAS ALSO NOTED THAT NOISE WAS INTERMITTENTLY SENSED WHILE THE PATIENT WAS SITTING IN THE CLINIC. NEITHER THE LOW IMPEDANCE OR THE NOISE COULD BE REPRODUCED WITH ISOMETRICS. AN INSULATION BREAK WAS SUSPECTED.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR