BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT ACCEL DR

    MDR report key: 4153482 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16437
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    July 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630459 CURRENT ACCEL DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death 7010/(B)(4), 1888TC/(B)(4)