BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 1934861 · Received December 21, 2010

    Report

    Report Number
    2017865-2010-05423
    Event Type
    Death
    Date Received
    December 21, 2010
    Date of Event
    November 21, 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
    MA
    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 WENT INTO AN ARRYTHMIA. THE RHYTHM DEGRADED TO A POINT WHERE THE LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WERE UNABLE TO ACCURATELY DETECT AND TREAT THE ARRYTHMIA. THE PATIENT EXPIRED ON (B)(6) 2010.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death CD3231-40, (B)(4)