BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARINR

    MDR report key: 2083007 · Received May 10, 2011

    Report

    Report Number
    2649622-2011-07460
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DRF
    PMA / PMN Number
    K931794
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ON THE TABLE, THE PHYSICIAN WAS ABLATING, AND THE TEMPERATURE SPIKED OUT OF RANGE WHILE THE WATTAGE DROPPED TO ZERO WITHIN MILLISECONDS. ANOTHER PATIENT HAD JUST BEEN SUCCESSFULLY ABLATED. THE PHYSICIAN REPLACED THE CATHETER AND ABLATION WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARINR ABLATION DIAGNOSTIC CATHETER DRF MEDTRONIC PUERTO RICO, INC. 072402 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4802 ABLATION RF GENERATOR