BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 6064869 · Received October 28, 2016

    Report

    Report Number
    2938836-2016-13508
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    August 27, 2015
    Report Date
    October 7, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714361 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7001/65 0002146098

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death 1458Q/75, (B)(4)| 2088TC/46, (B)(4)| CD3265-40, (B)(4)