BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4130811 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16116
    Event Type
    Death
    Date Received
    September 30, 2014
    Date of Event
    August 30, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 10.3CM 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 PATIENT EXPIRED. 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. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607470 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death (B)(4), (B)(4)