BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS + DR DUAL-CHAMBER DEFIBRILLATOR

    MDR report key: 734111 · Received June 27, 2006

    Report

    Report Number
    2938836-2006-00493
    Event Type
    Malfunction
    Date Received
    June 27, 2006
    Date of Event
    June 2, 2006
    Report Date
    June 2, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC.CRMD
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL , INC., CRMD

    Description of Event or Problem · 1

    IT WAS REPORTED TO ST. JUDE MEDICAL THAT DURING A LEAD REVISION, THE ICD COULD NOT BE INTERROGATED. AS A RESULT, THE DEVICE WA REPLACED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS + DR DUAL-CHAMBER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.CRMD V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR THERAPY DATES: