BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10211328 · Received June 30, 2020

    Report

    Report Number
    2184149-2020-00092
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 24, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067003126
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    THERE WAS NO EGM DISPLAY ON THE WORKMATE CLARIS. THE CABLE CONNECTION WAS CHECKED AS WELL AS ANOTHER CABLE WHICH DID NOT RESOLVE THE ISSUE. THE STUDY WAS CANCELLED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676978 EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. 09-1462-0056 05415067003126

    Patients

    Seq Age Sex Outcome Treatment
    1