BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS DUO

    MDR report key: 1904434 · Received November 22, 2010

    Report

    Report Number
    2017865-2010-05360
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    April 26, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS OF THE CPS-DUO UNIT FOUND THAT THE STYLET WAS BROKEN AT 11.6 CM FROM THE WHITE HUB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POSITIONING OF THE LEFT VENTRICULAR LEAD, THE CPS-DUO ADAPTER PIN DISCONNECTED. DUE TO THIS, THE STYLET BROKE AND STUCK INSIDE THE LEAD. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPS DUO GUIDEWIRE DQY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DS2M007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1