BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS

    MDR report key: 104451 · Received July 11, 1997

    Report

    Report Number
    104451
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    June 9, 1997
    Report Date
    June 16, 1997
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LUMBAR SHUNT REVISION ON 6/9/97; A NEW VALVE WAS IMPLANTED. A MFR'S REP WAS PRESENT DURING THE PROCEDURE. ON 6/10/97, THE PT COMPLAINED OF A "PRESSURE FEELING IN THE HEAD" AND MALAISE. THE MFR'S REP CONTACTED THE NEUROSURGEON ON 6/11/97 THE INFORM THE SURGEON THE VALVE HAD BEEN IMPLANTED IN THE INCORRECT CONFIGURATION OF REVERSE FLOW. THE PT RETURNED TO SURGERY ON 6/13/97 FOR REMOVAL OF THE MALPOSITIONED VALVE AND INSERTION OF A NEW, CORRECTLY ALIGNED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS Implant LUMBAR VALVE & STEPDOWN CONNECTOR JXG ELEKTA INSTRUMENTS, INC. 903-325 98291 & 901415

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention