BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 8701425 · Received June 14, 2019

    Report

    Report Number
    2938836-2019-04825
    Event Type
    Death
    Date Received
    June 14, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 14, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    UDI-DI
    05414734502153
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04822, RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04826, RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04827. IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS LESS THAN A NORMAL RANGE, AND THE MEASURED VALUE OF THE LV END-SYSTOLIC DIAMETER WAS MORE THAN EXPECTED. THEREFORE, THE PATIENT WAS CLASSIFIED AS A HIGH-RISK PATIENT. HOWEVER, THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494513 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122/65 A000067737 05414734502153

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death QUADRA ASSURA MP ICD| QUARTET| TENDRIL STS