BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUARTET

    MDR report key: 6126198 · Received November 23, 2016

    Report

    Report Number
    2938836-2016-14748
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    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. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776255 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1458Q/92 A000013166

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death BSX, (B)(4)| LDA220Q/65, (B)(4)| MDT, (B)(4)