BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 7429552 · Received April 13, 2018

    Report

    Report Number
    2938836-2018-03432
    Event Type
    Death
    Date Received
    April 13, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 13, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. SEPTIC INFECTION IS REPORTED UNDER MANUFACTURER REPORT PER 2018-0043423.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR SEPTIC INFECTION, SYSTEM WAS EXPLANTED AND THE PATIENT WAS FINE POST PROCEDURE. FEW DAYS LATER, IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE WAS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271347 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122Q/65 A000046084

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death 1458QL/86, (B)(4)| CD3369-40Q, (B)(4)| LPA1200M/52, (B)(4)