BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPTH ELECTRODE

    MDR report key: 2440427 · Received January 31, 2012

    Report

    Report Number
    2183456-2012-00001
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    July 18, 2011
    Report Date
    January 27, 2012
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K053358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DECISION TO FILE THIS ADVERSE EVENT REPORT IS THE RESULT OF A DISCUSSION WITH A FDA INSPECTOR DURING A FACILITY INSPECTION. THE ADVERSE EVENT WAS RECORDED AT THE USER FACILITY. THE USER FACILITY REPORT "INCIDENT CODING ADVERSE EVENT" WAS RECORDED AS "USER ERROR." THE USER FACILITY REPORT "SEVERITY" WAS LISTED AS "MINOR."

    Description of Event or Problem · 1

    DURING AN OPERATIVE PROCEDURE FOR REMOVAL OF A DEPTH ELECTRODE, THE REGISTRAR HAD DIFFICULTY IN REMOVING THE ELECTRODE. WHEN PULLED, THE ELECTRODE BROKE AND THE TIP OF THE ELECTRODE IN QUESTION WAS LEFT INSIDE. AN EMERGENCY CT SCAN AND MINI CRANIOTOMY WAS DONE FOR THE REMOVAL OF THE TIP OF THE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH ELECTRODE GZL AD-TECH MEDICAL INSTRUMENT CORP. AD04R-SP10X-000 208140365

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention