BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 19292537 · Received May 10, 2024

    Report

    Report Number
    2135147-2024-02123
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    January 1, 2023
    Report Date
    June 4, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: ARTICLE TITLE: AMPLATZER SEPTAL OCCLUDER

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, ABRASION FOR TREATMENT OF ATRIAL TACHYCARDIA EARLY AFTER PLACEMENT: ONE EXAMPLE OF SUCCESSFUL IMPLEMENTATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. LITERATURE ATTACHMENT: ARTICLE TITLE: ABRASION FOR TREATMENT OF ATRIAL TACHYCARDIA EARLY AFTER PLACEMENT: ONE EXAMPLE OF SUCCESSFUL IMPLEMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. EARLY IN THE POSTOPERATIVE PHASE, ATRIAL TACHYCARDIA WAS DETECTED ON ELECTROCARDIOGRAM (ECG). AN ABLATION WAS PERFORMED, AND THE TACHYCARDIA RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 0

    AN ARTICLE, "ABRASION FOR TREATMENT OF ATRIAL TACHYCARDIA EARLY AFTER PLACEMENT: ONE EXAMPLE OF SUCCESSFUL IMPLEMENTATION", WAS REVIEWED. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. EARLY IN THE POSTOPERATIVE PHASE, ATRIAL TACHYCARDIA WAS DETECTED ON ELECTROCARDIOGRAM (ECG). AN ABLATION WAS PERFORMED, AND THE TACHYCARDIA RESOLVED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KEI HIRAMATSU, NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519426 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention