BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II XP

    MDR report key: 523157 · Received May 3, 2004

    Report

    Report Number
    2939222-2004-00022
    Event Type
    Injury
    Date Received
    May 3, 2004
    Date of Event
    March 31, 2004
    Report Date
    April 9, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR MDR 2939222-2004-00017 IN 4/2004, REP BELIEVED THE PHYSICIAN HAD DISCONTINUED USE OF THE BLAZER II XP CATHETERS AFTER HE PERFORMED A CASE WHERE THERE WERE 3 HOLES IN THE ATRIUM THAT CAUSED BLEEDING AND REQUIRED REPAIR. THIS IS BELIEVED TO BE ONE OF THREE INCIDENTS ON THE HOSPITAL'S VOLUNTARY MEDWATCH REPORT DATED 4/23/2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II XP CARDIAC ABLATION CATHETER LPB EP TECHNOLOGIES, INC. 4500THK2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| O| R