BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 6128843 · Received November 28, 2016

    Report

    Report Number
    2938836-2016-14653
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    August 4, 2015
    Report Date
    November 2, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PRIMARY 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
    780241 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1570/65 0002484058

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death (B)(4)| (B)(4)| (B)(4)