BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX

    MDR report key: 2923346 · Received January 22, 2013

    Report

    Report Number
    2017865-2013-01060
    Event Type
    Death
    Date Received
    January 22, 2013
    Date of Event
    January 22, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 SHE PRESENTED TO THE HOSPITAL WITH NAUSEA, VOMITING, DEHYDRATION AND ELEVATED WHITE BLOOD CELLS. SHE WAS DIAGNOSED WITH (B)(6). THE RIGHT ATRIAL LEAD WAS EXPLANTED. THE PATIENT DECEASED ON (B)(6) 2012 DUE TO RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31400 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death 2207-36, (B)(4), 7120, (B)(4)