BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1050926 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01865
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 18, 2008
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS CONFIRMED THE HARDWARE VVI (HWVVI) RESET IN THE LABORATORY. THE DEVICE WENT INTO HWVVI DURING DELIVERY OF A HIGH VOLTAGE SHOCK. X-RAY ANALYSIS REVEALED A BROKEN WIRE IN THE CONNECTOR HEAD. DUE TO THE OPEN CONNECTION, THE DEVICE DELIVERED INTO AN OPENED LOAD AND PUT THE DEVICE INTO HWVVI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A FIGHT. PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING INAPPROPRIATE SHOCK. THE DEVICE WAS EXPLANTED WHEN A HARDWARE RESET WAS OBSERVED.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE;CONTROLLER MALFUNCTION.SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION;INAPPROPRIATE ALARMS.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED.INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER.IMPLANT DEVICE TYPE: LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention