BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1073485 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02264
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 30, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED RESET WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS INTERROGATED AND FOUND TO BE IN HARDWARE BACKUP (HWVVI) MODE. AFTER DOWNLOADING AND ANALYZING THE DEVICE IMAGE, IT WAS FOUND THAT THE RESET OCCURRED SHORTLY AFTER THERAPY WAS DELIVERED INTO AN OPEN LOAD. TESTING REVEALED NORMAL DEVICE CHARACTERISTICS. AUTOMATED TESTING FOUND THE DEVICE PERFORMED AS EXPECTED; NO ANOMALIES WERE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO HARDWARE RESET. THE CONDITION OF THE PATIENT AFTER THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A LAPAROSCOPIC COLON RESECTION USING THE ETHICON DEXTRUS SEAL CAP ASSEMBLY. WHEN HE PLACED HIS HAND THROUGH THE SEAL, IT RIPPED INTO TWO PIECES . A NEW SEAL WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM.====================== HEALTH PROFESSIONAL'S IMPRESSION============================================ MANUFACTURER RESPONSE FOR SEAL CAP ASSEMBLY, ETHICON DEXTRUS SEAL CAP ASSEMBLY======================HAVE NOT HEARD FROM THEM YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention