BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6142490 · Received December 2, 2016

    Report

    Report Number
    2938836-2016-15319
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    November 4, 2016
    Report Date
    January 26, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL MDR IS NEEDED TO CORRECT THE EVALUATION CODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. DEVICE INTERROGATION WAS REQUESTED BY MEDICAL EXAMINER. THE DEVICE COULD NOT BE INTERROGATED AS THE BODY HAS BEEN UNDER REFRIGERATION SINCE THE DATE OF DEATH. THE PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE AND WAS NOT IN GOOD HEALTH. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791200 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122Q/58 A000003876

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death 1258T/86, (B)(4)| 1688TC/46, (B)(4)| CD3357-40Q, 7171055