BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER

    MDR report key: 8993722 · Received September 11, 2019

    Report

    Report Number
    2134265-2019-11017
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    UDI-DI
    08714729841968
    PMA / PMN Number
    K143481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. PT'S WEIGHT: (B)(6) KG.

    Description of Event or Problem · 1

    (B)(46 CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND A SMALL PERICARDIAL EFFUSION. AFTER AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OPEN-IRRIGATED AND AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, THE PATIENT SEEN IN THE EMERGENCY ROOM (ER) ON (B)(6) 2019 WITH COMPLAINTS OF CHEST PAIN. THE PATIENT WAS ADMITTED FOR OBSERVATION AND ONLY TREATED WITH PAIN MEDICATIONS; MORPHINE 2MG INTRAVENOUSLY. THE PATIENT HAD AN ECHOCARDIOGRAM, WHICH SHOWED SMALL PERICARDIAL EFFUSION. CHEST X-RAY WAS NEGATIVE. IT WAS NOTED THAT PATIENTS CHEST PAINED WORSENED WITH COUGH AND DEEP INHALATION. THE CAUSE WAS UNKNOWN. THE PATIENT'S OUTCOME WAS NOT RECOVERED/NOT RESOLVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790935 INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION 87035 0023720181 08714729841968

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R