BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 18-2D 2-DIAMETER SYNERG DETECTION CIRCUIT

    MDR report key: 405270 · Received July 11, 2002

    Report

    Report Number
    6000078-2002-00110
    Event Type
    Malfunction
    Date Received
    July 11, 2002
    Date of Event
    June 5, 2002
    Report Date
    July 11, 2002
    Manufacturer
    TARGET THERAPEUTICS, A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC-TARGET WAS NOTIFIED THAT DURING THE PROCEDURE THE GDC 18-2D 2-DIAMETER SYNERG DETECTION CIRCUIT DETACHED PRIOR TO ELECTROLYTIC ATTACHMENT. THE PRODUCT WAS DESTROYED. THE PT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 18-2D 2-DIAMETER SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG TARGET THERAPEUTICS, A DIVISION OF BOSTON SCIENTIFIC CORP * 3878645

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO