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

Model Number	RD10R-SP05X-000
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the description, the electrode was placed on (b)(6) 2024 and subsequently due to the amount of artifact replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrode recorded well with no artifact.The original electrode was discarded.
Event or Problem Description
On april 16,2024 an electrode was placed in a patient.The electrode was tested in the operating room and showed artifact however it was decided to leave it implanted.On (b)(6) 2024 due to the increasing amount of artifact the patient was taken back to the or for a second surgery to replace the electrode.There was no negative effect on the patient.
Event or Problem Description
On (b)(6) 2024 an electrode was placed in a patient.The electrode was tested in the operating room and showed artifact however it was decided to leave it implanted.On (b)(6) 2024 due to the increasing amount of artifact the patient was taken back to the or for a second surgery to replace the electrode.There was no negative effect on the patient.
Additional Manufacturer Narrative
As stated in the description, the electrode was placed on (b)(6) 2024 and subsequently due to the amount of artifact replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrode recorded well with no artifact.The original electrode was discarded.Updated 06/17/2024.The customer discarded the electrodes and was not able to supply lot or batch information.As a result, no device history record review or return analysis were conducted for this complaint.Due to limited information supplied by the customer along with the inability to examine the return device, no root cause could be identified.There are no corrective actions.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "alap".No further action is needed at this time.
Event or Problem Description
On (b)(6) 2024 an electrode was placed in a patient.The electrode was tested in the operating room and showed artifact however it was decided to leave it implanted.On (b)(6) 2024 due to the increasing amount of artifact the patient was taken back to the or for a second surgery to replace the electrode.There was no negative effect on the patient.
Additional Manufacturer Narrative
As stated in the description, the electrode was placed on (b)(6) 2024 and subsequently due to the amount of artifact replaced with a second surgery on (b)(6) 2024.There was no harm to the patient.The replacement electrode recorded well with no artifact.The original electrode was discarded.Updated 06/17/2024 the customer discarded the electrodes and was not able to supply lot or batch information.As a result, no device history record review or return analysis were conducted for this complaint.Due to limited information supplied by the customer along with the inability to examine the return device, no root cause could be identified.There are no corrective actions.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "alap".No further action is needed at this time.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 rd10r-sp05x-000.Primary di number- (b)(4) (mr) (b)(4) (ce).

• 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: 19220602
• Report Number: 2183456-2024-00005
• Device Sequence Number: 7025798
• Product Code: GZL
• UDI-Device Identifier: 00841823108920
• UDI-Public: 841823108920
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: RD10R-SP05X-000
• Device Catalogue Number: RD10R-SP05X-000
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 04/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/17/2024; 09/27/2024
• 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
• Patient Sex: Unknown