BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT RF DR

    MDR report key: 1932347 · Received December 17, 2010

    Report

    Report Number
    2017865-2010-05410
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    June 29, 2010
    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
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO DELAY IN RECEIVING PAPERWORK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. NO KNOWN CAUSE OR DEVICE ISSUE WAS REPORTED. 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 90 YR Death 1388T/46 (B)(4), 1580/60 (B)(4)