BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6063725 · Received October 28, 2016

    Report

    Report Number
    2938836-2016-13308
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT PER THE DEATH CERTIFICATE THE CAUSE OF DEATH WAS POLYSUBSTANCE TOXICITY AS DETERMINED BY AUTOPSY AND RULED ACCIDENTAL. THE DEATH IS NOT RELATED TO THE DEVICE, STUDY OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715838 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LDA220Q/58 4816574

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death (B)(4)| (B)(4)