BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2013938 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01527
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 14, 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
    GA
    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 IN VVI MODE PACING AND SENSING OF THE ATRIUM OCCURRED AND IN AAI MODE PACING AND SENSING OF THE VENTRICLE OCCURRED. IT WAS SUSPECTED THAT THE LEADS WERE REVERSED IN THE HEADER AT IMPLANT. THE POCKET WAS OPENED AND THE LEADS WERE VERIFIED TO BE IN THE CORRECT HEADER PORTS. AN EXTERNAL SOURCE OF INTERFERENCE WHILE USING THE TELEMETRY WAND COULD HAVE CAUSED THE ORIGINAL EGM'S. THE LEAD REMAINS IMPLANTED.

    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 1882TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PM2210, (B)(4), 1888TC/52, (B)(4)