BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATAKR II

    MDR report key: 2132026 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00234
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LPB
    PMA / PMN Number
    P930029/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE UNIT WAS RETURNED, ANALYZED, AND THE ANALYSIS FOUND THAT THE DISPERSIVE ELECTRODE CONNECTOR WAS BROKEN.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR 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. 4802 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other