BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPENCER DEPTH ELECTRODE

    MDR report key: 14414105 · Received May 16, 2022

    Report

    Report Number
    2183456-2022-00013
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 19, 2022
    Report Date
    November 16, 2022
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    UDI-DI
    00841823107695
    PMA / PMN Number
    K163355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT REPORTED THAT THE DEPTH ELECTRODE WAS SEVERED (BROKEN IN TWO) WHERE IT LOOKED LIKE THE ELECTRODE BROKE AT THE END OF THE ANCHOR BOLT. IT WAS DISCOVERED DURING EXPLANT WHEN ONLY PART OF THE ELECTRODE CAME OUT. AN ADDITIONAL SCAN WAS COMPLETED TO ENSURE THAT THE REMAINING PART OF THE ELECTRODE WAS INTACT AND THAT CONTACTS OR WIRES WERE NOT ADDITIONALLY SEPARATED FROM THE REMAINING PORTION OF THE DEPTH. ONCE THEY CONFIRMED THAT THE ELECTRODE ONLY SPLIT INTO TWO PARTS, THE REMAINING PORTION OF THE DEPTH WHICH WAS STICKING OUT OF THE DURA WAS REMOVED WITH A MICROGRASPER. COMPLAINANT STATED THAT THIS ONLY ADDED AN ADDITIONAL 20 MINUTES TO THE PROCEDURE AND THE PATIENT WAS RELEASED NEXT DAY (STANDARD PROCEDURE). THIS PATIENT WAS REPORTED TO HAVING HAD EXTREMELY VIOLENT SEIZURES DURING MONITORING. NO SPECIFIC INFORMATION REGARDING THE ELECTRODE CATALOG NUMBER, LOT, OR BATCH HAS BEEN RECEIVED BY THE USER FACILITY. THE ELECTRODE HAS NOT YET BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    COMPLAINANT REPORTED THAT THE DEPTH ELECTRODE WAS SEVERED (BROKEN IN TWO) WHERE IT LOOKED LIKE THE ELECTRODE BROKE AT THE END OF THE ANCHOR BOLT. IT WAS DISCOVERED DURING EXPLANT WHEN ONLY PART OF THE ELECTRODE CAME OUT. AN ADDITIONAL SCAN WAS COMPLETED TO ENSURE THAT THE REMAINING PART OF THE ELECTRODE WAS INTACT AND THAT CONTACTS OR WIRES WERE NOT ADDITIONALLY SEPARATED FROM THE REMAINING PORTION OF THE DEPTH. ONCE THEY CONFIRMED THAT THE ELECTRODE ONLY SPLIT INTO TWO PARTS, THE REMAINING PORTION OF THE DEPTH WHICH WAS STICKING OUT OF THE DURA WAS REMOVED WITH A MICROGRASPER. COMPLAINANT STATED THAT THIS ONLY ADDED AN ADDITIONAL 20 MINUTES TO THE PROCEDURE AND THE PATIENT WAS RELEASED NEXT DAY (STANDARD PROCEDURE). THIS PATIENT WAS REPORTED TO HAVING HAD EXTREMELY VIOLENT SEIZURES DURING MONITORING. NO SPECIFIC INFORMATION REGARDING THE ELECTRODE CATALOG NUMBER, LOT, OR BATCH HAS BEEN RECIEVED BY THE USER FACILITY. THE ELECTRODE HAS NOT YET BEEN RETURNED. UPDATED 11/16/2022. THE BREAK IN THE ELECTRODE OCCURRED BETWEEN THE 7TH AND 8TH CONTACT ON THE BRAIN END. THE 8TH CONTACT WAS CRUSHED AND SEVERELY DAMAGED IN THE TUBING AT THE BREAK LOCATION, AND THE ANCHOR BOLT CAP WAS ATTACHED TO THE ELECTRODE AT THE DAMAGED 8TH CONTACT. THE COMPLAINTANT STATED THAT THE PATIENT HAD EXTREMELY VIOLENT SEIZURES AND THE TRAJECTORY WAS VERY HIGH ON THE HEAD AT AN OBLIQUE ANGLE. THE MOST LIKELY CAUSE WOULD HAVE BEEN THE ELECTRODE RUBBING AGAINST THE BOLT THREAD DUE TO HOW IT WAS PLACED. THE RISK ASSESSMENT CONCLUDED THAT THE OCCURENCE LEVEL IS "ALAP" (AS LOW AS POSSIBLE).

    Description of Event or Problem · 0

    DURING EXPLANT, A DEPTH ELECTRODE FRAGMENT WAS RETAINED. EXTRA IMAGING AND UNPLANNED PROCEDURES WERE NECESSARY TO REMOVE THE FRAGMENT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    DURING EXPLANT, A DEPTH ELECTRODE FRAGMENT WAS RETAINED. EXTRA IMAGING AND UNPLANNED PROCEDURES WERE NECESSARY TO REMOVE THE FRAGMENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898704 SPENCER DEPTH ELECTRODE DEPTH ELECTRODE GZL AD-TECH MEDICAL INSTRUMENT CORP. SD08R-SP05X-000 780781782 00841823107695

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other