MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. MACRO DEPTH ELECTRODE

Model Number	BF10R-SP05X-0BH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode was explanted and the patient is ok.
Event or Problem Description
After an implant of an electrode the patient was showing signs of weakness and exhaustion.An additional ct scan was taken in which if showed that around the 10-contact frontal lobe branched hub of the electrode there was large air pocket which was causing pressure on the brain.
Event or Problem Description
After an implant of an electrode the patient was showing signs of weakness and exhaustion.An additional ct scan was taken in which it showed that around the 10-contact frontal lobe branched hub of the electrode there was large air pocket which was causing pressure on the brain.
Additional Manufacturer Narrative
The electrode was explanted and the patient is ok.Updated 5/29/25.The electrode was thrown away, so no investigation or root cause analysis was conducted to understand the event.

• Brand Name: MACRO DEPTH ELECTRODE
• Common Device Name: MACRO DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 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: 22046611
• Report Number: 2183456-2025-00005
• Device Sequence Number: 8880777
• Product Code: GZL
• UDI-Device Identifier: 00841823109668
• UDI-Public: 00841823109668
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/01/2026
• Device Model Number: BF10R-SP05X-0BH
• Device Catalogue Number: BF10R-SP05X-0BH
• Device Lot Number: 888889890
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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