BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COIL

    MDR report key: 554303 · Received November 10, 2004

    Report

    Report Number
    6000078-2004-00185
    Event Type
    Injury
    Date Received
    November 10, 2004
    Report Date
    November 10, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC NEUROVASCULAR WAS NOTIFIED OF A PT WHO SUFFERED FROM PARKINSON'S DISEASE WAS COILED IN 12/2003 FOR "GRANT PERIOHTELRIC" ANEURYSM. THE PT WAS COILED USING 16 MICROVENTION INC. HYDROCOILS AND APPROXIMATELY 11 MATRIX COILS. THE PT CAME BACK IN 06/2004 FOR AN ANGIOGRAM. THEY WERE SUBSEQUENTLY RETREATED WITH 3 ADDITIONAL MATRIX COILS. IN 07/2004, THE PT COMPLAINED THAT PT WAS NOT FEELING WELL. AN MRI INDICATED THAT PT HAD HYDROCEPHALUS. THE PT WAS HOSPITALIZED TO DUE A LUMBAR PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COIL DETACHABLE COIL HCG BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R MICROVENTION HYDROCOIL