BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-2D 2-D DIAMETER SYNERG DETECTION CIRCUIT

    MDR report key: 672143 · Received February 1, 2006

    Report

    Report Number
    6000078-2005-00271
    Event Type
    Malfunction
    Date Received
    February 1, 2006
    Date of Event
    November 25, 2005
    Report Date
    January 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.,NEUROVASCULAR DIV.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORP BECAME AWARE OF AN EVENT IN WHICH THE SUBJECT DEVICE UNRAVELLED DURING THE PROCEDURE. NO COMPLICATIONS WITH THE PT WERE REPORTED TO HAVE OCCURRED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-2D 2-D DIAMETER SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP.,NEUROVASCULAR DIV. * 7289847

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR