BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL

    MDR report key: 4903206 · Received July 9, 2015

    Report

    Report Number
    2184149-2015-00005
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K092810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. EXAMINATION OF THE WORKMATE LOGS RETURNED CONFIRMED A DEFIBRILLATION SHOCK WAS PERFORMED AND A SECOND ONE APPROXIMATELY 30 SECONDS LATER. THE WORKMATE LOGS ALSO CONFIRM THAT THE SYSTEM WAS RESTARTED ON THE REPORTED DATE. REVIEW OF THE STUDY INDICATED THE PATIENT WAS IN NORMAL SINUS RHYTHM AT STUDY START. COMMENTS IN THE STUDY INDICATED THE INTRODUCTION OF ATRIAL FIBRILLATION FOLLOWED BY WHAT APPEAR AS ATTEMPTS TO PACE OUT OF THE INDUCED RHYTHM PRIOR TO THE CARDIOVERSION. BASED ON THE STUDY PROVIDED, IT APPEARS THAT ATRIAL FIBRILLATION WAS STILL PRESENT PRIOR TO THE FIRST CARDIOVERSION RETURNING TO NORMAL SINUS RHYTHM AFTER. FURTHER, THERE ARE INTERMITTENT PACS WITH OTHERWISE NORMAL SINUS RHYTHM PRIOR TO THE SECOND CARDIOVERSION WITH NORMAL SINUS RHYTHM AFTER. WHILE WE ARE UNABLE TO CONFIRM, IT IS POSSIBLE THAT THE REPLAY ACTION WAS INITIATED FROM THE REVIEW SCREEN. SELECTING THE REPLAY BUTTON WILL REPLAY THE CURRENTLY DISPLAYED REVIEW IMAGE ON THE REAL-TIME MONITOR AT THE CURRENT DISPLAYED SPEED. SIGNALS WILL CONTINUE TO DISPLAY UNTIL THE REPLAY BUTTON IS PRESSED AGAIN OR THE RECORDING ENDS. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED DISPLAY DELAY REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE USER INDICATES THERE WAS A DELAY IN THE DISPLAY OF THE EKG ON THE RECORDING SYSTEM. THE DISPLAY INDICATED THE PATIENT WAS A PERSISTENT ARRHYTHMIA AND A SHOCK WAS DELIVERED; HOWEVER, REVIEW INDICATED THE PATIENT WAS IN SINUS RHYTHM PRIOR TO THE SHOCK. REBOOTING THE SYSTEM RESOLVED THE DISPLAY ISSUE.

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY PROCEDURE, AN UNNECESSARY SHOCK WAS DELIVERED WHILE THE PATIENT WAS IN SINUS RHYTHM. THE PATIENT REMAINED IN SINUS RHYTHM AND THERE WERE NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446123 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 09-1462-0056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other