BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4894847 · Received July 7, 2015

    Report

    Report Number
    2938836-2015-27708
    Event Type
    Death
    Date Received
    July 7, 2015
    Date of Event
    April 23, 2015
    Report Date
    June 9, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 9.2CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED FOR CREMATION. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438481 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LDA210Q/58 4597005

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death (B)(4)