BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME EP CATHETER, 5F, DECAPOLAR 5/5MM CSL

    MDR report key: 1012484 · Received March 12, 2008

    Report

    Report Number
    2182269-2008-00087
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS AWAITING DEVICE RETURN. ONCE THE ANALYSIS HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER SEPARATED DURING THE PROCEDURE BETWEEN THE OUTER LUMEN (BLACK) AND THE CURVE (GRAY); WIRES ARE VISIBLE. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER, 5F, DECAPOLAR 5/5MM CSL SUPREME EP, 5F DECA DRF ST. JUDE MEDICAL NA 2031991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK