BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSENSE WEBSTER CELSIUS THERMOCOOL CATHETER

    MDR report key: 860379 · Received June 5, 2007

    Report

    Report Number
    2029046-2007-00070
    Event Type
    Death
    Date Received
    June 5, 2007
    Date of Event
    April 2, 2007
    Report Date
    June 4, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE CATHETER USED WAS A BIOSENSE WEBSTER CELSIUS THERMOCOOL CATHETER. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CELSIUS THERMOCOOL CATHETER ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Death