SUBDURAL ELECTRODE
Report
- Report Number
- 2183456-2025-00007
- Event Type
- Malfunction
- Date Received
- August 18, 2025
- Report Date
- September 25, 2025
- Manufacturer
- AD-TECH MEDICAL INSTRUMENT CORP.
- Product Code
- GYC
- PMA / PMN Number
- K970587
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS MDR IS BEING FILED WITHIN 30 DAYS OF BECOMING AWARE OF THE RETAINED SUBDURAL ELECTRODE WHICH OCCURRED 20 YEARS AGO. THERE WAS NO CATALOG OR LOT INFORMATION PROVIDED FOR THIS EVENT. THERE HAS BEEN NO PATIENT HARM REPORTED WITH THE RETAINED ELECTRODE. THE 510(K) NUMBER REFERENCED IN THIS REPORT IS THAT WHICH AD-TECH SUBDURAL ELECTRODES WERE MARKETED UNDER IN 2005. THE CURRENT 510(K) NUMBER FOR AD-TECH SUBDURAL ELECTRODES IS K191186. THE CUSTOMER WAS EMAILED THE FOLLOWING RESPONSE: TO DATE, AD-TECH ONLY HAS FDA CLEARANCE FOR MRI USE OF DEPTH ELECTRODES (SPECIFICALLY SD AND RD S-STYLE ELECTRODES) AND ANCHOR BOLTS. AS STATED IN OUR INSTRUCTIONS FOR USE (IFU) FOR SUBDURALS, "THE SUBDURAL ELECTRODE HAS NOT BEEN EVALUATED FOR SAFETY AND COMPATIBILITY IN THE MR ENVIRONMENT. IT HAS NOT BEEN TESTED FOR HEATING, MIGRATION, OR IMAGE ARTIFACT IN THE MR ENVIRONMENT. THE SAFETY OF THE SUBDURAL ELECTRODE IN THE MR ENVIRONMENT IS UNKNOWN. SCANNING A PATIENT WHO HAS THIS DEVICE MAY RESULT IN PATIENT INJURY." ----REPORT FOLLOW-UP #01------ UPDATED 8/19/25. THE FAILURE TO EXPLANT THE ELECTRODE IS THE SOLE REASON FOR THIS REPORT. NO ADDITIONAL DEVICE MALFUNCTION OR PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. THIS INCIDENT IS NOT RELATED TO MRI USE. NO MRI PROCEDURE WAS PERFORMED IN CONNECTION WITH THE RETAINED ELECTRODE, AND NO ADVERSE EVENT INVOLVING MRI HAS OCCURRED. THE REPORT IS FILED SOLELY TO DOCUMENT THE RETENTION OF THE ELECTRODE.
THIS MDR IS BEING FILED WITHIN 30 DAYS OF BECOMING AWARE OF THE RETAINED SUBDURAL ELETRODE WHICH OCCURRED 20 YEARS AGO. THERE WAS NO CATALOG OR LOT INFORMATION PROVIDED FOR THIS EVENT. THERE HAS BEEN NO PATIENT HARM REPORTED WITH THE RETAINED ELECTRODE. THE 510(K) NUMBER REFERENCED IN THIS REPORT IS THAT WHICH AD-TECH SUBDURAL ELECTRODES WERE MARKETED UNDER IN 2005. THE CURRENT 510(K) NUMDER FOR AD-TECH SUBDURAL ELECTRODES IS K191186. THE CUSTOMER WAS EMAILED THE FOLLOWING RESPONSE: TO DATE, AD-TECH ONLY HAS FDA CLEARANCE FOR MRI USE OF DEPTH ELECTRODES (SPECIFICALLY SD AND RD S-STYLE ELECTRODES) AND ANCHOR BOLTS. AS STATED IN OUR INSTRUCTIONS FOR USE (IFU) FOR SUBDURALS, "THE SUBDURAL ELECTRODE HAS NOT BEEN EVALUATED FOR SAFETY AND COMPATIBILITY IN THE MR ENVIRONMENT. IT HAS NOT BEEN TESTED FOR HEATING, MIGRATION, OR IMAGE ARTIFACT IN THE MR ENVIRONMENT. THE SAFETY OF THE SUBDURAL ELECTRODE IN THE MR ENVIRONMENT IS UNKNOWN. SCANNING A PATIENT WHO HAS THIS DEVICE MAY RESULT IN PATIENT INJURY."
THIS MDR IS BEING FILED WITHIN 30 DAYS OF BECOMING AWARE OF THE RETAINED SUBDURAL ELETRODE WHICH OCCURRED 20 YEARS AGO. THERE WAS NO CATALOG OR LOT INFORMATION PROVIDED FOR THIS EVENT. THERE HAS BEEN NO PATIENT HARM REPORTED WITH THE RETAINED ELECTRODE. THE 510(K) NUMBER REFERENCED IN THIS REPORT IS THAT WHICH AD-TECH SUBDURAL ELECTRODES WERE MARKETED UNDER IN 2005. THE CURRENT 510(K) NUMDER FOR AD-TECH SUBDURAL ELECTRODES IS K191186. THE CUSTOMER WAS EMAILED THE FOLLOWING RESPONSE: TO DATE, AD-TECH ONLY HAS FDA CLEARANCE FOR MRI USE OF DEPTH ELECTRODES (SPECIFICALLY SD AND RD S-STYLE ELECTRODES) AND ANCHOR BOLTS. AS STATED IN OUR INSTRUCTIONS FOR USE (IFU) FOR SUBDURALS, "THE SUBDURAL ELECTRODE HAS NOT BEEN EVALUATED FOR SAFETY AND COMPATIBILITY IN THE MR ENVIRONMENT. IT HAS NOT BEEN TESTED FOR HEATING, MIGRATION, OR IMAGE ARTIFACT IN THE MR ENVIRONMENT. THE SAFETY OF THE SUBDURAL ELECTRODE IN THE MR ENVIRONMENT IS UNKNOWN. SCANNING A PATIENT WHO HAS THIS DEVICE MAY RESULT IN PATIENT INJURY." REPORT FOLLOW-UP #01 UPDATED 8/19/25. THE FAILURE TO EXPLANT THE ELECTRODE IS THE SOLE REASON FOR THIS REPORT. NO ADDITIONAL DEVICE MALFUNCTION OR PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. THIS INCIDENT IS NOT RELATED TO MRI USE. NO MRI PROCEDURE WAS PERFORMED IN CONNECTION WITH THE RETAINED ELECTRODE, AND NO ADVERSE EVENT INVOLVING MRI HAS OCCURRED. THE REPORT IS FILED SOLELY TO DOCUMENT THE RETENTION OF THE ELECTRODE. REPORT FOLLOW-UP #02 UPDATED 9/25/25. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED RETAINED ELECTRODE. UNFORTUNATELY, NO LOT NUMBER, BATCH NUMBER, OR CATALOG NUMBER WAS PROVIDED BY THE COMPLAINANT, WHICH HAS PREVENTED FURTHER INVESTIGATION INTO THE SPECIFIC PRODUCT INVOLVED. DUE TO THE LACK OF TRACEABLE PRODUCT INFORMATION, WE ARE UNABLE TO PROCEED WITH A ROOT CAUSE ANALYSIS OR DETERMINE ANY POTENTIAL CORRECTIVE ACTIONS. AS A RESULT, THIS COMPLAINT WILL BE FORMALLY CLOSED. SHOULD ANY NEW OR IDENTIFYING INFORMATION BECOME AVAILABLE, WE WILL REOPEN THE INVESTIGATION ACCORDINGLY.
ON AUGUST 6TH, 2025 A NEUROLOGIST EMAILED SEEKING GUIDANCE REGARDING A PATIENT WHO HAD A SUBDURAL ELECTRODE IMPLANTED APPROXIMATELY 20 YEARS AGO, WHICH, FOR UNKNOWN REASONS, WAS NOT EXPLANTED FOLLOWING THE PROCEDURE. THE CURRENT CLINICAL TEAM IS EVALUATING THE SAFETY OF PERFORMING AN MRI SCAN ON THIS PATIENT. ---REPORT FOLLOW-UP #01------ UPDATED 08/19/25. THE FAILURE TO EXPLANT THE ELECTRODE IS THE SOLE REASON FOR THIS REPORT. NO ADDITIONAL DEVICE MALFUNCTION OR PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. THIS INCIDENT IS NOT RELATED TO MRI USE. NO MRI PROCEDURE WAS PERFORMED IN CONNECTION WITH THE RETAINED ELECTRODE, AND NO ADVERSE EVENT INVOLVING MRI HAS OCCURRED. THE REPORT IS FILED SOLELY TO DOCUMENT THE RETENTION OF THE ELECTRODE.
ON AUGUST 6TH, 2025 A NEUROLOGIST EMAILED SEEKING GUIDANCE REGARDING A PATIENT WHO HAD A SUBDURAL ELECTRODE IMPLANTED APPROXIMATELY 20 YEARS AGO, WHICH, FOR UNKNOWN REASONS, WAS NOT EXPLANTED FOLLOWING THE PROCEDURE. THE CURRENT CLINICAL TEAM IS EVALUATING THE SAFETY OF PERFORMING AN MRI SCAN ON THIS PATIENT.
ON AUGUST 6TH, 2025 A NEUROLOGIST EMAILED SEEKING GUIDANCE REGARDING A PATIENT WHO HAD A SUBDURAL ELECTRODE IMPLANTED APPROXIMATELY 20 YEARS AGO, WHICH, FOR UNKNOWN REASONS, WAS NOT EXPLANTED FOLLOWING THE PROCEDURE. THE CURRENT CLINICAL TEAM IS EVALUATING THE SAFETY OF PERFORMING AN MRI SCAN ON THIS PATIENT. REPORT FOLLOW-UP #01 UPDATED 08/19/25. THE FAILURE TO EXPLANT THE ELECTRODE IS THE SOLE REASON FOR THIS REPORT. NO ADDITIONAL DEVICE MALFUNCTION OR PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. THIS INCIDENT IS NOT RELATED TO MRI USE. NO MRI PROCEDURE WAS PERFORMED IN CONNECTION WITH THE RETAINED ELECTRODE, AND NO ADVERSE EVENT INVOLVING MRI HAS OCCURRED. THE REPORT IS FILED SOLELY TO DOCUMENT THE RETENTION OF THE ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1761874 | SUBDURAL ELECTRODE | SUBDURAL ELECTRODE | GYC | AD-TECH MEDICAL INSTRUMENT CORP. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |