MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORPORATION SUBDURAL ELECTRODE

Model Number	TS06R-SP10X-000
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information on the impact to the patient was provided at the time of this report.Two attempts for additional information requests were sent out to the customer.This report will be updated if additional information is provided from the customer.
Event or Problem Description
The doctor was unable to remove the platinum electrode from the patient.
Additional Manufacturer Narrative
No information on the impact to the patient was provided at the time of this report.Two attempts for additional information requests were sent out to the customer.This report will be updated if additional information is provided from the customer.---updated (b)(6) 2025---- the customer reported the electrode was removed by bedside with gentle traction.During the removal a contact loosened from the electrode and remained within the patient.There was no reported impact to the patient and there is no plan to remove the remnants from the patient.The customer was informed of our product limitations of intended temporary (29 days or less) use.They are not intended for implantation longer than this period.Also surgical removal (not bedside) is the approved method.This information is all included with the instructions for use.
Event or Problem Description
The doctor was unable to remove the platinum electrode from the patient.

• Brand Name: SUBDURAL ELECTRODE
• Common Device Name: SUBDURAL ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORPORATION; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORPORATION; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 20864748
• Report Number: 2183456-2024-00012
• Device Sequence Number: 8838459
• Product Code: GYC
• UDI-Device Identifier: 00841823108128
• UDI-Public: 00841823108128
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K191186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TS06R-SP10X-000
• Device Catalogue Number: TS06R-SP10X-000
• Device Lot Number: 882883884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown