BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 5091325 · Received September 21, 2015

    Report

    Report Number
    2017865-2015-28674
    Event Type
    Death
    Date Received
    September 21, 2015
    Date of Event
    July 21, 2014
    Report Date
    September 3, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED; THE CAUSE OF DEATH WAS REPORTED AS CARDIAC DYSRHYTHMIA. ADDITIONAL INFORMATION NOTED CARDIAC TAMPONADE DUE TO COMPLICATIONS OF PACEMAKER PLACEMENT AND SINUS NODE DYSFUNCTION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621753 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 4630066

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death