BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL DX

    MDR report key: 3851799 · Received June 5, 2014

    Report

    Report Number
    2017865-2014-13822
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENTS CAUSE OF DEATH WAS ASPIRATION PNEUMONIA, ESOPHAGEAL FOOD BOLUS OBSTRUCTION AND VALVULAR DISEASE. THE DEATH WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328954 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1388T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death (B)(4)