BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 2905261 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00783
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 25, 2012
    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 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 TWO DAYS POST IMPLANT IT WAS NOTED THAT THE LEAD PERFORATED THE PATIENT. THE PATIENT DEVELOPED PNEUMOTHORAX. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND THE PATIENT WAS -STABLE-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10888 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention