BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURE QUADRA RF CRT-P

    MDR report key: 4997727 · Received August 12, 2015

    Report

    Report Number
    2017865-2015-27612
    Event Type
    Death
    Date Received
    August 12, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NKE
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528545 ALLURE QUADRA RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR NKE ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM3242 4591381

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 2088TC/46, (B)(4)