BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLAZER II HTD

    MDR report key: 603015 · Received May 16, 2005

    Report

    Report Number
    2939222-2005-00012
    Event Type
    Other
    Date Received
    May 16, 2005
    Date of Event
    February 16, 2005
    Report Date
    May 13, 2005
    Manufacturer
    BOSTON SCIENTIFIC EPT
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER DESCRIPTION: "WE BELIEVE THAT THE TEMPERATURE CONTROL WAS BAD, BECAUSE ON THE EPT ABLATION GENERATOR THE SELECTOR WOULD NOT DEFAULT TO "TEMPERATURES", WHICH ACCORDING TO THE EPT TECH SUPPORT IT IS SUPPOSED TO DO EACH TIME THE CAHTETER IS CONNECTED TO THE AUTOMATIC PERSONALITY MODULE (APM). FURTHERMORE, THE GENERATOR COULD NOT BE MANUALLY CHANGED TO THE "TEMPERATURE" SELECTION. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT IS SUPPOSED TO DO." INITIAL COMPLAINT DESCRIPTION ONLY STATED, "WOULD NOT WORK PROPERLY". STILL WAITING FOR THE FOLLOWING INFORMATION FROM THE RISK MANAGEMENT STAFF: CORRECTIVE ACTION, PROCEDURE OUTCOME AND PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II HTD THEJRAPEUTIC CATHETERS DQO BOSTON SCIENTIFIC EPT M004 5031TK2 0 7103111

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other