BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-3D 3D-SHAPE SYNERG DETECTION

    MDR report key: 557745 · Received December 2, 2004

    Report

    Report Number
    6000078-2004-00215
    Event Type
    Malfunction
    Date Received
    December 2, 2004
    Date of Event
    September 29, 2004
    Report Date
    November 30, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED THAT DURING AN EVENT WHEN THE GDC 10-3D-SHAPE SYNERG DETECTION CIRCUIT WAS INSERTED INTO THE LESION, RESISTANCE OCCURRED. NO COMPLICATIONS WITH THE PT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-3D 3D-SHAPE SYNERG DETECTION DETACHABLE COIL HCG BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * 5352849

    Patients

    Seq Age Sex Outcome Treatment
    1 * EXCELSIOR SL-10 MICROCATHETER.