BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2014149 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01376
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 19, 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
    PA
    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 GREATER THAN 2500 OHMS IMPEDANCE IN BOTH THE UNIPOLAR AND BIPOLAR CONFIGURATIONS WITH ELEVATED THRESHOLDS. SIX MONTHS PRIOR, LEAD IMPEDANCE WAS APPROXIMATELY 420 OHMS WITH NOMINAL THRESHOLDS. A CHEST X-RAY WAS PLANNED.

    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 1488T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR