BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL-TIP RF SYS 117V ENG

    MDR report key: 883238 · Received July 18, 2007

    Report

    Report Number
    1717344-2007-00214
    Event Type
    Death
    Date Received
    July 18, 2007
    Date of Event
    October 22, 2002
    Report Date
    July 2, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THIS INCIDENT WAS DOCUMENTED IN PUBLISHED LITERATURE AND WAS NOT DIRECTLY REPORTED TO VALLEYLAB. INFORMATION REPORTED BY ATTENDING SURGEON. A MALE PATIENT WITH PULMONARY FIBROSIS, CARDIOVASCULAR DISEASE, AND BILATERAL STAGE I ADENOCARCINOMA FELT TO BE SYNCHRONOUS PRIMARIES. BOTH SIDES TREATED ON SEPARATE DAYS. PATIENT DID WELL AND 3 DAYS LATER RETURNED SHORT OF BREATH REQUIRING INTUBATION. FELT TO BE EXACERBATION OF IPF WHICH IS KNOWN TO OCCUR AFTER BIOPSY. PATIENT HAD TERMINAL EXTUBATION BY PATIENT AND FAMILY WISHES AFTER FLYING HOME IN MILITARY JET AMBULANCE IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SYS 117V ENG COOL-TIP RF ABLATION SYSTEM GEI VALLEYLAB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death