BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE CPU

    MDR report key: 1940753 · Received December 22, 2010

    Report

    Report Number
    2184149-2010-00039
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DQK
    PMA / PMN Number
    K092810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A F/U REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EP4 SWITCHED FROM F5 TO F3 WENCKEBACH WHICH CAUSED THE PT TO GO INTO ATRIAL FIBRILLATION. THE CUSTOMER ADMITS THAT NO ONE MONITORS THE PACING DURING CASES. THEREFORE, THEY DID NOT WITNESS THE DECREMENT OF THE PACING INTERVAL UNTIL IT WENT DOWN TO 200MS FROM 600MS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKMATE CPU NONE DQK ST. JUDE MEDICAL, AF DIVISION WM-CPU-WIN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other