BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4929730 · Received July 21, 2015

    Report

    Report Number
    2938836-2015-28175
    Event Type
    Death
    Date Received
    July 21, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 5, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORT THAT THE PATIENT EXPIRED DURING EXTRACTION OF THE DEVICE AND ALL LEADS DUE TO INFECTION. THE PHYSICIAN DID NOT ALLEGE THAT THE DEVICE OR THE LEADS CAUSED THE INFECTION. IT WAS ALSO STATED THAT THE PATIENT'S CONDITION BEGAN TO WORSEN DURING THE LEAD EXTRACTION AND LATER THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470678 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7000/60 0002211130

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 1488TC/52, (B)(4)| 2088TC/46, (B)(4)| CD3231-40, (B)(4)| 2088TC/52, (B)(4)| 1056T/86, (B)(4)