BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR

    MDR report key: 220577 · Received April 17, 1999

    Report

    Report Number
    2020638-1999-00010
    Event Type
    Injury
    Date Received
    April 17, 1999
    Date of Event
    March 16, 1999
    Report Date
    March 17, 1999
    Manufacturer
    CORDIS WEBSTER INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE DELIVERING RF CURRENT IN RVOT, THERE WAS AN IMPEDANCE RISE AND AN AUDIBLE POP. THE PT CODED AND AN ATTEMPT WAS MADE TO TAP THE PERICARDIUM. THE PT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR. THE PT SURVIVED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR MAPPING CATHETER DQO CORDIS WEBSTER INC. NS7-FL-174-HS 901371

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R