BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 5010377 · Received August 18, 2015

    Report

    Report Number
    2938836-2015-28458
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    June 21, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS HYPERTENSIVE AND ARTERIOSCLEROSIS CARDIOVASCULAR DISEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544242 IMPANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) V-243

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death