BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1050528 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01279
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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 AUTOCAPTURE WAS OPERATING IN HIGH-OUTPUT MODE (5 VOLTS). CAPTURE THRESHOLDS WERE 6 V, 1.0 MS IN THE BIPOLAR CONFIGURATION. THE LONG TERM THRESHOLD RECORD REVELAED A DRASTIC INCREASE IN VENTRICULAR THRESHOLDS IN PAST WEEKS.

    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 1688T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention