BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL

    MDR report key: 7086516 · Received December 6, 2017

    Report

    Report Number
    2184149-2017-00067
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 16, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED COMMUNICATION ISSUE WAS ISOLATED TO ABNORMAL FUNCTIONALITY OF THE SINGLE BOARD COMPUTER. AC POWER WAS APPLIED TO THE EP-4 STIMULATOR WHICH FAILED TO SUCCESSFULLY EXECUTE THE POWER ON SELF-TEST OR ESTABLISH COMMUNICATION WITH THE TOUCHSCREEN COMPUTER. 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 ABLE TO COMMUNICATE WITH THE TOUCHSCREEN. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865928 EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ ST. JUDE MEDICAL, INC. 09-1527-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EP-WORKMATE¿ EP-4¿ TOUCHSCREEN COMPUTER