BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUARTET

    MDR report key: 3942553 · Received July 17, 2014

    Report

    Report Number
    2017865-2014-15730
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    December 1, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENTS CAUSE OF DEATH WAS RESPIRATORY ARREST AND CARCINOMA LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418631 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death (B)(4)