BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR

    MDR report key: 6985298 · Received October 27, 2017

    Report

    Report Number
    2184149-2017-00029
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    August 22, 2017
    Report Date
    February 14, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WORKMATE CLARIS COMPUTER LOGS WERE RETURNED AND INVESTIGATED. A COMPREHENSIVE REVIEW OF THE EVENTS LOG REVEALED THAT THE HALT KEY WAS PRESSED MULTIPLE TIMES ON 2 SEPARATE OCCASIONS NEAR THE END OF THE PROCEDURE AS REPORTED. THE LOG INDICATED THE HALT KEY WAS PRESSED 5 TIMES WITHIN A 1 SECOND TIMEFRAME; HOWEVER, BASED ON THE INFORMATION FROM THE EVENTS LOG, THE PACING WAS TERMINATED AS STIMULATION WAS AGAIN INITIATED SHORTLY AFTER. THE RESULTS OF THE BASIC EP APPLICATION TESTING CONFIRMED NO ABNORMAL OPERATING SYMPTOM OR UNEXPECTED SYSTEM BEHAVIOR DURING THE COURSE OF THE SIMULATING TEST STUDY.

    Additional Manufacturer Narrative · 1

    THE REPORTED PACING ISSUE WAS UNABLE TO BE CONFIRMED. THE STIMULATOR WAS SENT TO (B)(4) FOR FURTHER INVESTIGATION. BASED ON THE INFORMATION PROVIDED TO ABBOTT, THE CAUSE OF THE ISSUE REMAINS UNKNOWN AS THE ISSUE WAS NOT REPLICATED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PATIENT DEVELOPED AN ARRHYTHMIA. THE STIMULATOR WOULD NOT STOP PACING AND THE EP-4 DISPLAY SCREEN CHANGED FROM BLUE TO GRAY AFTER THE PACING WAS GIVEN TEN TIMES. PACING WAS DISCONTINUED BY PRESSING THE ¿HALT¿ KEY. ALTHOUGH THE PATIENT DEVELOPED AN ARRHYTHMIA WHILE PACING, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762452 WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR JOQ ST. JUDE MEDICAL, INC. EP-4-04 5674924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other