BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH ELECTRODE

    MDR report key: 13001693 · Received December 14, 2021

    Report

    Report Number
    2183456-2021-00014
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    April 1, 2001
    Report Date
    December 13, 2021
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K964644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED WITHIN 30 DAYS OF AD-TECH BECOMING AWARE OF THE RETAINED DEPTH COLLAR WHICH OCCURED APPROXIMATELY 20 YEARS AGO. PHYSICIAN WAS NOT ABLE TO PROVIDE SPECIFIC USER FACILITY (POTENTIALLY (B)(6) IN (B)(6)), ELECTRODE MANUFACTURER (AD-TECH OR PMT), CATALOG NUMBER, OR LOT INFORMATION FOR THIS EVENT. THERE HAS BEEN NO PATIENT HARM REPORTED WITH THE RETAINED CONTACT. THE IMPLANT DATE IS APPROXIMATE, BASED ON PHYSICIAN NOTES OF (B)(6) 2001. THE 510(K) NUMBER REFERENCED IN THIS REPORT IS THAT WHICH AD-TECH DEPTH ELECTRODES WERE MARKETED UNDER IN 2001. THE CURRENT 510(K) NUMBER FOR AD-TECH DEPTH ELECTRODES IS K163355.

    Description of Event or Problem · 0

    ON (B)(6) 2021, AD-TECH'S CUSTOMER SUPPORT WAS CONTACTED INQUIRING ABOUT THE CONTACT MATERIAL OF DEPTH ELECTRODES. THE PHYSICIAN COMMUNICATED THAT THEY HAD A PATIENT WITH A RETAINED ELECTRODE CONTACT WITHIN THE BRAIN FROM EARLY 2001, AND WANTED TO KNOW IF THE CONTACT WAS MADE OF STAINLESS STEEL OR PLATINUM AT THAT TIME. THEY ALSO STATED THAT THEY WERE NOT CERTAIN IF IT WAS AN AD-TECH OR PMT ELECTRODE. AS THERE WAS NO COMPLAINT OR MDR RECORD FROM THAT TIME PERIOD, THIS MDR IS BEING FILED AS A CONSERVATIVE MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901531 DEPTH ELECTRODE DEPTH ELECTRODE GZL AD-TECH MEDICAL INSTRUMENT CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other