BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-STANDARD SYNERG DETECTION CIRCUIT

    MDR report key: 357649 · Received October 19, 2001

    Report

    Report Number
    6000078-2001-00079
    Event Type
    Malfunction
    Date Received
    October 19, 2001
    Date of Event
    September 13, 2001
    Report Date
    October 19, 2001
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BSC/TARGET THAT THE GDC 10-STANDARD SYNERG DETECTION CIRCUIT BROKE AWAY FROM THE PUSHER WIRE. THE DEVICE WAS RETRIEVED AND ANOTHER WAS PLACED. THE OUTCOME OF THE PROCEDURE WAS SUCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47127 GDC 10-STANDARD SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO BRAND NAME: 1. PROWLER-14 MICROCATHER.| BRAND NAME: 2. GDC SYNERG POWER SUPPLY,| CATALOG#: 451006-4.