BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER - 20 MM

    MDR report key: 8621675 · Received May 17, 2019

    Report

    Report Number
    2182208-2019-00924
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    May 2, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DRF
    PMA / PMN Number
    K162892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. THE CASE WAS ABORTED; HOWEVER, THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414747 ACHIEVE MAPPING CATHETER - 20 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC MEXICO 990063-020 217299672

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L