BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 6216877 · Received December 31, 2016

    Report

    Report Number
    2938836-2016-24016
    Event Type
    Death
    Date Received
    December 31, 2016
    Date of Event
    October 26, 2016
    Report Date
    April 8, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AT HOME. 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 CARDIAC PUMP FAILURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866846 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1580/65 0002199445

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death (B)(4)| (B)(4)| (B)(4)