BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4153631 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16449
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION: THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT FELL AT HOME AND WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE AND TACHY THERAPY WAS DISABLED. AT AUTOPSY, IT WAS FOUND THAT THE PATIENT HAD A SUBDURAL HEMORRHAGE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631668 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death CD3231-40/737722,1688TC/DN210694,1258T/(B)(4)