BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1896158 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05007
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 4, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 DURING A UNIPOLAR AUTOCAPTURE TEST POST IMPLANT, THE PATIENT FLATLINED. THE TEST WAS CANCELLED AND PROGRAMMING SET TO VVI 100 AT 7.5 V UNIPOLAR, HOWEVER LOSS OF CAPTURE CONTINUED. CARDIAC PERFORATION WITH A SMALL EFFUSION WAS DISCOVERED. THE LEAD WAS REPOSITIONED, AFTER WHICH NORMAL CAPTURE WAS OBSERVED.

    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 87 YR Required Intervention