BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT DR RF

    MDR report key: 6147670 · Received December 6, 2016

    Report

    Report Number
    2938836-2016-15401
    Event Type
    Death
    Date Received
    December 6, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 15, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    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 CONGESTIVE HEART FAILURE. OTHER CONDITIONS LISTED ARE CHRONIC RENAL DISEASE, HYPERTENSION, AND ATRIAL FIBRILLATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800201 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 2207-36 2753029

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death (B)(4)| (B)(4)