BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 6129146 · Received November 28, 2016

    Report

    Report Number
    2017865-2016-07352
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 5, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P030035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 RIGHT MIDDLE CEREBRAL ARTERY STROKE AND NON-ST SEGMENT MYOCARDIAL INFARCTION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779850 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2210 3980717

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death (B)(4)| (B)(4)