BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3181075 · Received June 20, 2013

    Report

    Report Number
    2938836-2013-02798
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO SEPSIS. THE CAUSE OF THE INFECTION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280897 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CD3251-40Q,1059663,1944,CPG033857,1458Q,BPU040440