BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATAKR II

    MDR report key: 2813615 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01892
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE, THE RF GENERATOR WAS SHOWING HIGH TEMPERATURES AND A MESSAGE WAS RECEIVED INDICATING CALIBRATION REQUIRED, CONTACT SERVICING. AN ALTERNATIVE RF GENERATOR WAS THEN USED TO COMPLETE THE PROCEDURE. THE RF GENERATOR HAS BEEN REPLACED BY A LOAN UNIT AND THE ORIGINAL WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATAKR II ABLATION RF GENERATOR LPB MEDTRONIC MILACA INC. 4803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other