BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7685100 · Received July 13, 2018

    Report

    Report Number
    2184149-2018-00106
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 19, 2018
    Report Date
    July 13, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067003126
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE AMPLIFIER 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 SIGNAL LOSS AND SUBSEQUENT CANCELLATION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FLUTTER ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO SIGNAL LOSS. FOLLOWING PATIENT PREPARATION ECG SIGNALS WERE DISPLAYED AS EXPECTED BUT WHEN THE CATHETER WAS CONNECTED TO THE RECORDING SYSTEM, NO INTRACARDIAC SIGNALS WERE AVAILABLE. THE PROCEDURE WAS CANCELLED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529977 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 09-1462-0056 05415067003126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other