BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1896494 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05088
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 PATIENT PRESENTED WITH LOSS OF VENTRICULAR CAPTURE AT MAXIMUM OUTPUT AND DIAPHRAGMATIC STIMULATION. THE LEAD WAS REPOSITIONED AND THE POCKET CLOSED. AN HOUR OR SO LATER, LOSS OF VENTRICULAR CAPTURE WAS AGAIN NOTED IN THE BIPOLAR CONFIGURATION. UNIPOLAR CAPTURE WAS INTERMITTENT AT 5 V. ATTEMPTS TO REPOSITION THE DISLODGED LEAD FAILED. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention