MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SPENCER PROBE DEPTH ELECTRODE; ELECTRODE, DEPTH

Model Number	SD10R-SP05X-000
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the description, the electrodes were placed on (b)(6) 2024 and subsequently due to the flat readings were replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrodes recorded well.
Event or Problem Description
On (b)(6) 2024 electrodes were implanted in the patient.On april 11th, some of the electrode readings were completely flat.After trouble shooting and changing cables it was decided to replace the electrodes.On april 12th,a second surgery was completed for the replacement of the electrodes.There was no reported harm to the patient.
Event or Problem Description
On (b)(6) 2024, electrodes were implanted in the patient.On (b)(6), some of the electrode readings were completely flat.After trouble shooting and changing cables it was decided to replace the electrodes.On (b)(6), a second surgery was completed for the replacement of the electrodes.There was no reported harm to the patient.
Additional Manufacturer Narrative
As stated in the description, the electrodes were placed on (b)(6) 2024 and subsequently due to the flat readings were replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrodes recorded well.Updated 6/3/2024.The clinical specialist and director of engineering were on site for the removal of the original electrodes.After the removal, the electrodes tested within the required parameters thus refuting the complaint.The issue was discussed with the clinicians on site and all were unable to identify the cause of the flat readings.As a recommendation for future use of electrodes the clinicians were told to be mindful of kinking the electrodes and tracking other equipment used to see if that is a factor in flat readings.
Additional Manufacturer Narrative
As stated in the description, the electrodes were placed on (b)(6) 2024 and subsequently due to the flat readings were replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrodes recorded well.Updated on 6/3/2024: the clinical specialist and director of engineering were on site for the removal of the original electrodes.After the removal, the electrodes tested within the required parameters thus refuting the complaint.The issue was discussed with the clinicians on site and all were unable to identify the cause of the flat readings.As a recommendation for future use of electrodes the clinicians were told to be mindful of kinking the electrodes and tracking other equipment used to see if that is a factor in flat readings.Updated on 09/27/2024: "udi related data quality updates only" clarification and correction of the following missing items from previous supplemental report: combination product: no brand name: spencer probe delth electrode.Model and catalog number sd10r-sp05x-000.Primary di number (b)(4).
Event or Problem Description
On (b)(6) 2024 electrodes were implanted in the patient.On (b)(6) 2024, some of the electrode readings were completely flat.After trouble shooting and changing cables it was decided to replace the electrodes.On (b)(6) 2024, a second surgery was completed for the replacement of the electrodes.There was no reported harm to the patient.

• Brand Name: SPENCER PROBE DEPTH ELECTRODE
• Common Device Name: ELECTRODE, DEPTH
• 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: 19222661
• Report Number: 2183456-2024-00006
• Device Sequence Number: 6941913
• Product Code: GZL
• UDI-Device Identifier: 00841823109354
• UDI-Public: 841823109354
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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: SD10R-SP05X-000
• Device Catalogue Number: SD10R-SP05X-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 04/11/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/03/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown