BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - NAVISTAR THERMOCOOL TC

    MDR report key: 1581919 · Received January 13, 2010

    Report

    Report Number
    2029046-2010-00003
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 7, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE REQUESTS TO THE AFFILIATE, BIOSENSE WEBSTER, INC. HAS NOT BEEN PROVIDED WITH ANY ADDITIONAL INFORMATION IN REGARDS TO THIS COMPLAINT, THE DETAILS OF THE PRODUCT IN QUESTION, ANY INFORMATION ABOUT THE PT, OR THE PROCEDURE PERFORMED. IF THE PRODUCT IS RETURNED TO BIOSENSE WEBSTER, INC. IN THE FUTURE, AN ANALYSIS WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    AF, PALPITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERIC - NAVISTAR THERMOCOOL TC OAD CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR THERMO TC UNK_NAVISTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening