BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 6210038 · Received December 28, 2016

    Report

    Report Number
    2017865-2016-08039
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 3, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECEASED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIOPULMONARY ARREST MYOCARDIAL ISCHEMIC CONDITION. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860007 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 4170217

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death (B)(4) | (B)(4)