BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT RF DR

    MDR report key: 2243091 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06197
    Event Type
    Death
    Date Received
    September 11, 2011
    Date of Event
    March 31, 2009
    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
    MS
    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

    IT WAS REPORTED THAT THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death 1888TC/46, (B)(4), 7120/60, (B)(4)