BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-SOFT SYNERG DETECTION CIRCUIT

    MDR report key: 402856 · Received June 28, 2002

    Report

    Report Number
    6000078-2002-00112
    Event Type
    Malfunction
    Date Received
    June 28, 2002
    Date of Event
    May 29, 2002
    Report Date
    June 28, 2002
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BSC/TARGET THAT, "STRETCHED COIL, ORIGINALLY THOUGHT TO HAVE PREMATURELY DETACHED". UPON EVALUATION IT WAS DISCOVERED THAT THE GDC PUSHER WIRE WAS BROKEN THEREFORE THE COMPLAINT BECAME AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-SOFT SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP * 4343238

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO