BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 2902578 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00442
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 23, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE DEVICE WAS INTERROGATED AND FOUND IN BACKUP VVI. AN ARC MARK WAS NOTED ON THE DEVICE CAN; FURTHER EVALUATION INDICATED THE PRESENCE OF LEAD MATERIAL. THE DEVICE IMAGE WAS REVIEWED AND THE RESET WAS FOUND TO HAVE BEEN CAUSED BY A POWER-ON RESET. THE CAUSE OF THE POWER-ON RESET WAS HV DELIVERY INTO LOW IMPEDANCE. THE ROOT CAUSE OF THE OUTPUT CIRCUIT DAMAGE WAS A LEAD ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL AFTER RECEIVING A VIBRATORY ALERT. UPON INTERROGATION, THE DEVICE WAS FOUND IN HARDWARE RESET MODE. THE PATIENT PREVIOUSLY HAD TACHY THERAPIES TURNED OFF. THE DEVICE WAS SUCCESSFULLY TAKEN OUT OF DEVICE RESET AND WAS ABLE TO BE INTERROGATED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO BACKUP VVI MODE. PATIENT WAS FINE AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9481 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention