BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    MDR report key: 8701820 · Received June 14, 2019

    Report

    Report Number
    2183456-2019-00004
    Event Type
    Injury
    Date Received
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE DESCRIPTION, ON (B)(6) 2019, IT WAS BROUGHT TO AD-TECH'S ATTENTION BY AN FDA INSPECTOR THAT THEIR CLINICAL SPECIALISTS (SALES DEPARTMENT) MAY BE SENDING CUSTOMERS MRI INFORMATION FOR SUBDURAL AND DEPTH ELECTRODES UPON REQUEST. QA/REGULATORY WAS UNAWARE OF THIS AND UPON QUESTIONING, WAS ABLE TO CONFIRM THAT THE CLINICAL SPECIALISTS WERE IN FACT SENDING THIS INFORMATION. ACCORDING TO THE DIRECTIONS FOR USE (DFUS) FOR SUBDURAL AND DEPTH ELECTRODES, IT IS STATED THAT THE ELECTRODES HAVE NOT BEEN EVALUATED FOR SAFETY AND COMPATIBILITY IN THE MR ENVIRONMENT. THEY HAVE NOT BEEN TESTED FOR HEATING, MIGRATION, OR IMAGE ARTIFACT IN THE MR ENVIRONMENT. THE SAFETY OF THE ELECTRODES IN THE MR ENVIRONMENT IS UNKNOWN. THIS AFFECTS ALL AD-TECH SUBDURALS, DEPTHS, AND ANCHOR BOLTS: SUBDURAL PRODUCT CODE: GYC SUBDURAL 510(K): K053363. DEPTH PRODUCT CODE: GZL DEPTH 510(K): K163355. ANCHOR BOLT PRODUCT CODE: GZL ANCHOR BOLT 510(K): K181544. NO ADVERSE EVENTS HAVE BEEN REPORTED RELATED TO THIS SUPPLEMENTARY LABELING.

    Description of Event or Problem · 1

    ON (B)(6) 2019, IT WAS BROUGHT TO AD-TECH'S ATTENTION BY AN FDA INSPECTOR THAT THEIR CLINICAL SPECIALISTS (SALES DEPARTMENT) MAY BE SENDING CUSTOMERS MRI INFORMATION FOR SUBDURAL AND DEPTH ELECTRODES UPON REQUEST. QA/REGULATORY WAS UNAWARE OF THIS AND UPON QUESTIONING, WAS ABLE TO CONFIRM THAT THE CLINICAL SPECIALISTS WERE IN FACT SENDING THIS INFORMATION. ACCORDING TO THE DIRECTIONS FOR USE (DFUS) FOR SUBDURAL AND DEPTH ELECTRODES, IT IS STATED THAT THE ELECTRODES HAVE NOT BEEN EVALUATED FOR SAFETY AND COMPATIBILITY IN THE MR ENVIRONMENT. THEY HAVE NOT BEEN TESTED FOR HEATING, MIGRATION, OR IMAGE ARTIFACT IN THE MR ENVIRONMENT. THE SAFETY OF THE ELECTRODES IN THE MR ENVIRONMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492088 SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS GZL AD-TECH MEDICAL INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1