BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 4130798 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16239
    Event Type
    Death
    Date Received
    September 30, 2014
    Date of Event
    July 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENTS FOLLOWING PHYSICIAN SEARCHED LOCAL HOSPITAL RECORDS AND FOUND THAT THE PATIENT WAS DIAGNOSED WITH STAGE 4 LUNG CANCER IN (B)(6) 2014 AND PRESENTED TO THE ER (B)(6) 2014 DUE TO SHORTNESS OF BREATH. THE HOSPITAL NOTES STATED THE PATIENT DID NOT WANT ANY INTERVENTIONS AND WAS REFERRED FOR HOSPICE CARE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608467 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 2207-36, 4849931888TC/(B)(4)