BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL INC.

    MDR report key: 2403641 · Received January 3, 2012

    Report

    Report Number
    MW5023713
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 3, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MECHANISM TO MANEUVER CATHETER FAILED. LOOP ON END OF CATHETER LOOPED AROUND CATHETER ITSELF AND WAS UNABLE TO BE MANIPULATED FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL INC. REFLEXION SPIRAL VARIABLE RADIUS CATHETER DRF ST. JUDE MEDICAL, INC. 3461875

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other