BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6128680 · Received November 28, 2016

    Report

    Report Number
    2938836-2016-14533
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    October 9, 2016
    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
    TN, 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 UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780552 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LDA220Q/65 A000008594

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death (B)(4)| (B)(4)