BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2090193 · Received May 16, 2011

    Report

    Report Number
    2135147-2011-00046
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THE INCIDENT SINCE THE DEVICE REMAINS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, TRANSIENT SVT OCCURRED DURING THE CATH PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE AND REQUIRED CARDIOVERSION X1 WITH SPONTANEOUS RETURN TO NORMAL SINUS RHYTHM AFTER CARDIOVERSION. THIS EVENT IS CURRENTLY BEING REVIEWED BY AGA MEDICAL'S DATA SAFETY MONITORING BOARD. IF ANY NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO HER PRIMARY MD'S OFFICE ON (B)(6) 2011 WITH COMPLAINTS OF PALPITATIONS. THE PATIENT WAS INITIALLY NOTED TO BE IN NORMAL SINUS RHYTHM BUT REPEAT EKG DEMONSTRATED ATRIAL FIBRILLATION. THE PATIENT WAS SENT TO ORMC FOR ADMISSION, MEDICAL MANAGEMENT/CARDIOVERSION AND FURTHER TESTING. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 IN NORMAL SINUS RHYTHM ON CARDIZEM. CARDIOVERSION WAS NOT PERFORMED. THE PATIENT AGAIN PRESENTED TO ORMC ED WITH COMPLAINTS OF PALPITATIONS, SHORTNESS OF BREATH AND CHEST PAIN. THE PATIENT REPORTED THE EPISODES BEGAN ON (B)(6) 2011 AND SHE NOTIFIED EMS. WHEN EMS ARRIVED, PALPITATIONS HAD RESOLVED AND THE PATIENT DID NOT GO TO THE EMERGENCY ROOM. THE PATIENT REPORTED PALPITATIONS ON AND OFF THE ENTIRE DAY OF (B)(6) 2011 WITH ACCOMPANYING SHORTNESS OF BREATH AND CHEST PAIN. THESE EVENTS ARE CURRENTLY BEING REVIEWED BY AGA MEDICAL'S DATA SAFETY MONITORING BOARD. IF ANY NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-024 0910165896

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention