BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 2872122 · Received December 6, 2012

    Report

    Report Number
    2017233-2012-00811
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    May 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PT. THE REVIEW OF THE MFG RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE HELEX SEPTAL OCCLUDER ON 05/03/2012 TO CLOSE A PT FORAMEN OVALE. DURING A F/U VISIT ON (B)(6) 2012 THE PT WAS DIAGNOSED WITH ATRIAL ECTOPIC TACHYCARDIA AND WAS STARTED ON FLECAINIDE. FURTHER EXAMINATION SHOWED A POSITIVE BUBBLE STUDY. THE PT WAS WEANED OFF FLECAINIDE AFTER 2-3 MONTHS AND IS NOW DOING FINE WITH NO FURTHER ARRHYTHMIA ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER MLV / OCCLUDER, TRANSCATHETER SEPTAL MLV W.L. GORE & ASSOCIATES 10002703

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other