BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - NAVISTAR THERMOCOOL TC

    MDR report key: 1955443 · Received January 10, 2011

    Report

    Report Number
    2029046-2011-00002
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 14, 2010
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION PROCEDURE FOR PAROXYMAL ATRIAL FIBRILLATION AS PART OF (B)(4) ON (B)(6) 2010. PATIENT REPORTED PALPITATIONS ON (B)(6) 2010. THE STUDY INVESTIGATOR CONSIDERED THIS EVENT AS ANTICIPATED, NON-SERIOUS AND NOT-PRODUCT RELATED. HENCE, THE EVENT WAS NOT CONSIDERED AS A REPORTABLE EVENT. ON (B)(6) 2010, BIOSENSE WEBSTER WAS ALERTED WITH AN UPDATED EVENT DESCRIPTION BY THE STUDY INVESTIGATOR, INDICATING THAT THE PATIENT REPORTED PALPITATIONS AND WAS ANXIOUS AT THAT TIME. THE PATIENTS MEDICATION WAS NOT CHANGED. THE INVESTIGATOR DECIDED THAT THE PALPITATIONS WERE TRANSIENT PALPITATIONS DUE TO INFLAMMATORY TACHYCARDIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1