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	03/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 an electrode was implanted in the patient.On (b)(6) the electrode readings were flat resulting in a second surgery for the replacement of the electrode.There was no reported harm to the patient.
Additional Manufacturer Narrative
As stated in the description, the electrode was placed on (b)(6) 2024 and subsequently due to the flat readings was replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrode recorded well.This report is past the 30 day time frame due to the first review of the complaint on (b)(6) 2024 was deemed not reportable.A second similiar complaint was recevived and after a team discussion this was reviewed as a reportable incident as well.Updated 5-8-24.The complaint was discussed with engineering.Testing scenarios were discussed in attempt to explain the failure in the field after 5 days of use and why the electrode tested within range during the return analysis.Prior to the attempt to recreate the scenarios, the electrode was retested, confirming all contacted tested in range.Additional testing scenarios: 1.Bent electrode-the electrode was bent at an extreme angle and retested.This round of testing failed.Only contact 2 tested in range- all other contacts had no connection.The contact was straightened and visually inspected.There was no evidence of the bend visible on the body of the electrode.It was retested and all contacts tested in range.2.Anchor bolt- one lsbk1-ax-05 was placed on the electrode and tightened beyond the recommended 5 times in the dfu.I was able to turn it 7 times in total by hand, potentially it could have been tightened more in the field.The electrode was retested and all contacts tested in range except contact 3 which tested significantly over the acceptable range.The anchor bolt was removed and the electrode retested.All contacts tested in range.While we do not have a definitive root cause, we have identified scenarios where the electrode could have failed in the field but tested within range when returned.There are no corrective actions at this time.The complaint will be closed and the trend code monitored.
Additional Manufacturer Narrative
As stated in the description, the electrode was placed on (b)(6) 2024 and subsequently due to the flat readings was replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrode recorded well.This report is past the 30 day time frame due to the first review of the complaint on (b)(6) 2024 was deemed not reportable.A second similiar complaint was received and after a team discussion this was reviewed as a reportable incident as well.
Event or Problem Description
On (b)(6) 2024 an electrode was implanted in the patient.On march 24th, the electrode readings were flat resulting in a second surgery for the replacement of the electrode.There was no reported harm to the patient.
Additional Manufacturer Narrative
As stated in the description, the electrode was placed on (b)(6) 2024 and subsequently due to the flat readings was replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrode recorded well.This report is past the 30-day time frame due to the first review of the complaint on 3-28-2024 was deemed not reportable.A second similar complaint was received and after a team discussion this was reviewed as a reportable incident as well.Updated 5-8-2024: the complaint was discussed with engineering.Testing scenarios were discussed in attempt to explain the failure in the field after 5 days of use and why the electrode tested within range during the return analysis.Prior to the attempt to recreate the scenarios, the electrode was retested, confirming all contacted tested in range.Additional testing scenarios: 1.Bent electrode-the electrode was bent at an extreme angle and retested.This round of testing failed.Only contact 2 tested in range- all other contacts had no connection.The contact was straightened and visually inspected.There was no evidence of the bend visible on the body of the electrode.It was retested and all contacts tested in range.2.Anchor bolt- one lsbk1-ax-05 was placed on the electrode and tightened beyond the recommended 5 times in the dfu.I was able to turn it 7 times in total by hand, potentially it could have been tightened more in the field.The electrode was retested and all contacts tested in range except contact 3 which tested significantly over the acceptable range.The anchor bolt was removed and the electrode retested.All contacts tested in range.While we do not have a definitive root cause, we have identified scenarios where the electrode could have failed in the field but tested within range when returned.There are no corrective actions at this time.The complaint will be closed and the trend code monitored.Updated 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, an electrode was implanted in the patient.On (b)(6), the electrode readings were flat resulting in a second surgery for the replacement of the electrode.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: 19229445
• Report Number: 2183456-2024-00007
• Device Sequence Number: 20250279
• 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: Other Health Care Professional
• 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
• Device Lot Number: 858859860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 03/25/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/08/2024; 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