BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3781861 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10035
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    November 14, 2013
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. INITIAL REPORTER PROFESSION: UNKNOWN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 8.6CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    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
    258852 DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7170Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death CD3211-36Q/696422,1156T/AGT28615,1688TC/DN199566