BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANDLER TRANSLUMINAL V-PACING PROBE WITH AMC THROMBOSHIELD

    MDR report key: 1011926 · Received March 10, 2008

    Report

    Report Number
    6000002-2008-06180
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED, THE THRESHOLD VALUE WAS HIGH, BUT THERE WAS NO PROBLEM PACING. IT WAS FURTHER REPORTED THAT ON THE NEXT DAY AFTER THE INCISION, IT BECAME UNABLE TO PACE AND SENSE PRESSURE. THERE WAS TRACE OF THE PT PULLING THE CATHETER OUT. NO PT COMPLICATIONS WERE REPORTED. ANOTHER CATHETER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHANDLER TRANSLUMINAL V-PACING PROBE WITH AMC THROMBOSHIELD TRANSLUMINAL BIPOLAR PACING PROBE LDF EDWARDS LIFESCIENCES D98100H 236HC318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other