BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVEWIRE TC, UNIV, TEMP MONIT, QUAD., XLS, MEDCRL

    MDR report key: 2823521 · Received July 25, 2008

    Report

    Report Number
    2182269-2008-00388
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LPB
    PMA / PMN Number
    P960016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS AWAITING DEVICE RETURN. ONCE WE HAVE COMPLETED OUR INVESTIGATION, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ABLATION OF A LEFT KENT, THE CATHETER BECAME STUCK IN THE MITRAL VALVE CHORDS. DESPITE SEVERAL ATTEMPTS TO REMOVE THE CATHETER, IT REMAINED STUCK. THE PT WAS TRANSFERRED TO AN EMERGENCY SURGERY UNIT OF ANOTHER HOSPITAL ((B)(6)) WHERE HE UNDERWENT A THORACOTOMY WITH EXTRA-CORPOREAL CIRCULATION. THE SURGEON MANAGED TO ACCESS THE LEFT VENTRICLE OF THE PT AND REMOVE THE CATHETER. HE EXPLAINED THAT ONE THE CHORDS WAS WRAPPED AROUND THE CATHETER. THE PT WAS REPORTEDLY RECOVERING AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVEWIRE TC, UNIV, TEMP MONIT, QUAD., XLS, MEDCRL LIVEWIRE TC UNIV. XLS LPB ST. JUDE MEDICAL NA 2069990

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other