BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL

    MDR report key: 7330183 · Received March 12, 2018

    Report

    Report Number
    2184149-2018-00036
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 17, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE INTRACARDIAC SIGNALS WOULD NOT DISPLAY ON THE LIVE SCREEN OR THE REVIEW SCREEN. THE ECG CABLE WAS REPLACED WITH NO RESOLUTION SO THE PROCEDURE WAS CANCELED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175027 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 09-1463-0120

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other