BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 2408048 · Received January 10, 2012

    Report

    Report Number
    2017865-2012-08500
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    October 28, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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 WHEN THE VENTRICULAR LEAD WAS PLACED, IT PERFORATED BOTH THE RIGHT AND LEFT VENTRICLES. THE LEAD WAS REPOSITIONED AND PERFORATION OCCURRED AGAIN. CARDIAC TAMPONADE WAS CONFIRMED VIA ECG AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT'S HEART TISSUE WAS NOTED TO BE THIN -LIKE TISSUE PAPER- AND THE PATIENT WAS LISTED IN CRITICAL CONDITION. THE LEAD WAS LEFT IN PLACE AND MONITORING OF THE PATIENT WOULD CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 2088TC/52, (B)(4)