BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1955829 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00816
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    September 28, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED LOW IMPEDANCE OF 110 OHMS AND LOW SENSING THRESHOLD BETWEEN 3 AND 0.8 MV. TWO EPISODES OF NOISE WERE ALSO NOTED, WHICH WERE CONSISTENT WITH PRESUMABLE INSULATION DAMAGE. PROGRAMMING WAS CHANGED TO VENTRICULAR ONLY.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR