BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHILLI ABLATION CATHETER

    MDR report key: 516727 · Received March 19, 2004

    Report

    Report Number
    2939222-2004-00011
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    February 16, 2004
    Report Date
    February 17, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS FOR THE SECOND OF TWO EVENTS THAT OCCURRED DURING A SINGLE PROCEDURE (SEE MDR 2939222-2004-00010 FOR THE FIRST EVENT. THE ACTUAL SEQUENCE OF EVENTS IS UNK). AT THE END OF THE MAPPING AND ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT), THE PT COMPLAINED OF CHEST PAIN. THESE SYMPTOMS WERE ASSOCIATED WITH ST ELEVATION NOTED ON THE 12-LEAD ECG ON LEADS 1 AND AVL THAT RESOLVED ALMOST ENTIRELY WITH NITROGLYCERINE (NTG) SPRAY, YET SOME CHEST PAIN PERSISTED. THE PT UNDERWENT CORONARY ANGIOGRAPHY FOLLOWING THE EP PROCEDURE THAT SHOWED NO CHANGE IN CORONARY ANATOMY OR FILLING DEFECTS FROM THE CORONARY ANGIOGRAPHY STUDY PERFORMED IN 2003. THE CHEST DISCOMFORT WAS PROBABLY TWO DIMENSIONAL IN ORIGIN; THE FIRST BEING ANGINA AS EVIDENCED BY THE ST CHANGES ON THE ECG LEADS RESPONDING TO THE NTG SPRAY AND THE SECOND OF MUSCULAR-SKELETAL ORIGIN THAT HAD A LONGER DURATION THAT PROBABLY RESULTED FROM THE CARDIOVERSION DURING THE VT ABLATION PROCEDURE. THE PT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILLI ABLATION CATHETER COOLED RF ABLATION CATHETER LPB EP TECHNOLOGIES, INC. 3006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention