BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4173902 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16665
    Event Type
    Death
    Date Received
    October 15, 2014
    Date of Event
    December 15, 2012
    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 Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT HAD A HISTORY OF EMERGENCY ROOM VISITS DUE TO COPD, BRONCHITIS, PNEUMONIA, AND CHF. HE WAS ADVISED TO QUIT SMOKING. THE CLINIC LOST CONTACT WITH THE PATIENT AFTER (B)(6), 2012. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT WHEN IN (B)(6) 2014, A FAMILY MEMBER REQUESTED ALL CONTACT TO STOP AS THE PATIENT HAD EXPIRED. RECORDS RETRIEVED BY THE CLINIC NOTED THAT THE PATIENT WAS ADMITTED IN (B)(6) 2012 FOR DYSPNEA, HYPOXIA, AND PNEUMONIA. IT WAS ALSO NOTED THAT THE PATIENT WAS ON AMIODARONE FOR RECURRENT CARDIAC ARRHYTHMIA. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE PATIENT OR DEVICE INTERROGATION RECORDS, AND WAS UNABLE TO DETERMINE IF THE DEVICE HAD ANY RELATION TO THE PATIENT DEATH. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655224 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death (B)(4)