BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR

    MDR report key: 7118976 · Received December 14, 2017

    Report

    Report Number
    2184149-2017-00074
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    October 16, 2017
    Report Date
    January 5, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO CONCLUSION CODE AVAILABLE. THE STIMULATOR WAS RECEIVED FOR ANALYSIS AND THE REPORTED EVENT OF A COMMUNICATION ISSUE WAS CONFIRMED. IT WAS ALSO CONFIRMED THAT THE STIMULATOR FAILED TO SUCCESSFULLY EXECUTE THE POST (POWER ON SELF-TEST) AND COMMUNICATE WITH THE EP-4 TOUCHSCREEN PC, WHICH CONFIRMED THE REPORTED ISSUE. TESTING ISOLATED THE SINGLE BOARD COMPUTER AS THE ROOT CAUSE OF THE COMMUNICATION ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE STIMULATOR WAS NOT RESPONDING. ALL CONNECTIONS WERE CHECKED AND ATTEMPTS WERE MADE TO CONNECT THE TOUCHSCREEN DIRECTLY TO THE PC BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895586 WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR JOQ ST. JUDE MEDICAL, INC. H403023 6071383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other