BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT RF VR

    MDR report key: 2864082 · Received December 10, 2012

    Report

    Report Number
    2017865-2012-10526
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    June 20, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE CAUSE OF 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
    1 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death 7120, (B)(4)