BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1200423 · Received October 20, 2008

    Report

    Report Number
    2135147-2008-00096
    Event Type
    Injury
    Date Received
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE: NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM THE ARTICLE "TRANSCATHETER CLOSURE OF CONGENITAL VSD: RESULTS OF THE EUROPEAN REGISTRY". TWO PATIENTS EXPERIENCED AN ADVERSE EFFECT FOLLOWING IMPLANT OF AN AMPLATZER OCCLUDER. THE ARTICLE IS ATTACHED. THE FOLLOWING IS A SUMMARY OF THE TWO DEVICE APPROVED FOR USE BY THE FDA: PATIENT#1 - DURING CLOSURE WITH AN ASD DEVICE, THE PATIENT EXPERIENCED COMPLETE AVB AND WAS REFERRED FOR SURGICAL CLOSURE OF THE DEFECT. PATIENT#2 - FOLLOWING CLOSURE WITH A PDA DEVICE, THE PATIENT EXPERIENCED COMPLETE AVB AND REQUIRED PACEMAKER IMPLANTATION WITHIN FIVE DAYS OF DEVICE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER AMPLATZER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention