BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL ST

    MDR report key: 6212553 · Received December 29, 2016

    Report

    Report Number
    2938836-2016-23715
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 2, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863778 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1888TC/52 3249953

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 1258T/75, (B)(4)| 7121/65, (B)(4)| CD3357-40C, (B)(4)