BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS MULTI- DIAMETER CSR

    MDR report key: 1263281 · Received December 12, 2008

    Report

    Report Number
    2029214-2008-00206
    Event Type
    Injury
    Date Received
    December 12, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 14, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. MODEL AND LOT NUMBERS INVOLVED: ADD'L MODEL: X-2-2-T10-HSS, ADD'L LOT#: 4656520, ADD'L DATE MANUFACTURE: 12-2007, ADD'L EXPIRATE DATE:12-2012. ADD'L MODEL: X-2-1-T10-HSS, ADD'L LOT#: 5282606 (2EA), ADD'L DATE MANUFACTURE: 03-2008, ADD'L EXPIRATE DATE: 03-2013. ADD'L MODEL: X-2-1-T10-HSS, ADD'L LOT#: 5389679 (3EA), ADD'L DATE MANUFACTURE: 03/2008, ADD'L EXPIRATE DATE:03-2013. ADD'L MODEL: X-2-1-T-10-HSS, ADD'L LOT#: 5328633 (2EA), ADD'L DATE MANUFACTURE: 03-2008, ADD'L EXPIRATE DATE:03-2013. ADD'L MODEL: X-2-1-T10-HSS, ADD'L LOT# INCOMPLETE LOT # REPORTED.

    Description of Event or Problem · 1

    TEN COILS WERE USED IN AN ANEURYSM COILING PROCEDURE. POST PROCEDURE, IT WAS REPORTED PATIENT DEVELOPED DIPLOPIA AND THE PHYSICIAN OBSERVED A METALLIC ARTIFACT IN THE LEFT THALAMUS (FROM MRI IMAGES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS MULTI- DIAMETER CSR ELECTROLYTICALLY DETACHABLE COIL HCG EV3 NEUROVASCULAR X-2-2-T10-HSS 4715359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability