BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 18-STANDARD SYNERG DETECTION CIRCUIT

    MDR report key: 766754 · Received September 28, 2006

    Report

    Report Number
    6000078-2006-00502
    Event Type
    Injury
    Date Received
    September 28, 2006
    Report Date
    August 21, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    k991134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT WAS IMPLANTED INTO THE PATIENT. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADD'L PMA/510(K)# K001083.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE PATIENT SUFFERED A STROKE FOLLOWING THE TREATMENT OF AN ANEURYSM. IMAGING REVEALED A POSSIBLE INFLAMMATORY REACTION SURROUNDING THE TREATED ANEURYSM. THE PHYSICIAN REPORTED HE WILL PROVIDE BOSTON SCIENTIFIC A FULL WRITTEN REPORT AND IMAGES FOR INVESTIGATION WHICH WILL INCLUDE THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 18-STANDARD SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 350930-4 5992826

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention MATRIX2 SOFT 360 SR 8MM X 20CM.| GDC-18 2D 20MM X 30CM.| GDC-18 360 18MM X 40CM.| GDC-18 STANDARD 10MM X 30CM.| MATRIX2 ULTRASOFT 360 SR 4MM X 6CM.| GDC-10 STANDARD 8MM X 30CM.| MATRIX2 SOFT 360 SR 8MM X 30CM.| MATRIX2 STANDARD 360 SR 7MM X 20CM.| MATRIX2 STANDARD 360 SR 9MM X 30CM.| GDC-18 2D 18MM X 30CM.| MATRIX2 FIRM 360 18MM X 30CM.| MATRIX2 STANDARD 360 SR 12MM X 30CM.| MATRIX2 SOFT 360 SR 8MM X 30CM.| GDC-18 2D 12MM X 30CM.| GDC-18 2D 14MM X 30CM.| GDC-18 STANDARD 9MM X 30CM.| GDC-18 STANDARD 9MM X 30CM.| MATRIX2 SOFT 360 SR 4MM X 8CM.| MATRIX2 ULTRASOFT 360 SR 4MM X 8CM.| MATRIX2 ULTRASOFT 360 SR 5MM X 15CM.| MATRIX2 SOFT 360 SR 7MM X 20CM.| MATRIX2 SOFT 360 SR 7MM X 20CM.| GDC-18 2D 18MM X 30CM.| GDC-18 360 18MM X 40CM.| GDC-18 360 20MM X 33CM.| GDC-18 360 20MM X 33CM.| MATRIX2 FIRM 360 20MM X 30CM.| GDC-18 360 22MM X 40CM.| GDC-18 360 22MM X 40CM.| MATRIX2 FIRM 360 24MM X 40CM.| MATRIX2 STANDARD 360 SR 8MM X 20CM.| MATRIX2 STANDARD 360 SR 7MM X 20CM.| MATRIX2 STANDARD 360 SR 7MM X 20CM.| MATRIX2 STANDARD 360 SR 8MM X 30CM.| MATRIX2 STANDARD 360 SR 8MM X 30CM.| GDC-18 360 12MM X 30CM.| MATRIX2 STANDARD 360 SR 10MM X 30CM.