BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS+ VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 730770 · Received June 30, 2006

    Report

    Report Number
    2938836-2006-00507
    Event Type
    Injury
    Date Received
    June 30, 2006
    Date of Event
    April 23, 2006
    Report Date
    April 23, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ST. JUDE MEDICAL REPRESENTATIVE PHONE TO REQUEST ANALYSIS OF EGMS DISPLAYING NOISE. IT WAS REPORTED THAT THE NOISE WAS REPRODUCED WITH EXTENSIVE POCKET MANIPULATION. TECHNICAL SERVICES DISCUSSED THAT THE NOISE COULD BE RELATED TO AN INSULATION BREACH OR A LOOSE SET SCREW. TECHNICAL SERVICES RECOMMENDED PERFORMING ADDITIONAL POSITIONAL AND ISOMETRIC TESTING. THE ST. JUDE MEDICAL REPRESENTATIVE LATER REPORTED THAT THE NOISE WAS DUE TO A LOOSE SET SCREW ON THE VENTRICULAR SENSE/PACE LEAD. THE CASE WAS CLINICALLY RESOLVED BY OPENING THE POCKET AND RE-SEATING THE SETSCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS+ VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM LWS ST. JUDE MEDICAL, INC., CRMD V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 1581/65, RG15373, THERAPY DATES: NA