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

Model Number SD08R-SP05X-000

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

On march 2, 2023, ad-tech's customer support manager was contacted via email, by a customer stating that twelve (12) depth electrodes were placed in a patient on (b)(6) 2023.The patient was then brought back into surgery on post op day 3 to have eight (8) electrodes replaced on (b)(6) 2023 due to increasing artifact on the eeg.There was no injury to the patient, however a second surgery was needed for replacement of electrodes.On (b)(6) 2023, fda sent ad-tech the associated user facility report (b)(4), which had been submitted by the customer.

Manufacturer Narrative

As stated in the event description, on march 2, 2023, ad-tech's customer support manager was contacted via email, by a customer stating that twelve (12) depth electrodes were placed in a patient on (b)(6) 2023.The patient was then brought back into surgery on post op day 3 to have eight (8) electrodes replaced on (b)(6) 2023 due to increasing artifact on the eeg.There was no injury to the patient, however a second surgery was needed for replacement of electrodes.On march 23, 2023, fda sent ad-tech the associated user facility report (b)(4), which had been submitted by the customer.Additional lot numbers were identified in this event: sd08r-sp05x-000, lot# 0156088807808809.Sd08r-sp05x-000, lot# 0156892810811812.Sd12r-sp05x-000, lot# 0155859804805806.Sd12r-sp05x-000, lot# 0155369804805806.Sd12r-sp05x-000, lot# 0157433810811812.

Manufacturer Narrative

As stated in the event description, on march 2, 2023, ad-tech's customer support manager was contacted via email, by a customer stating that twelve (12) depth electrodes were placed in a patient on (b)(6) 2023.The patient was then brought back into surgery on post op day 3 to have eight (8) electrodes replaced on (b)(6) 2023 due to increasing artifact on the eeg.There was no injury to the patient, however a second surgery was needed for replacement of electrodes.On march 23, 2023, fda sent ad-tech the associated user facility report (b)(4), which had been submitted by the customer.Additional lot numbers were identified in this event: sd08r-sp05x-000, lot# 0156088807808809; sd08r-sp05x-000, lot# 0156892810811812; sd12r-sp05x-000, lot# 0155859804805806; sd12r-sp05x-000, lot# 0155369804805806; sd12r-sp05x-000, lot# 0157433810811812.Updated 8/04/2023: the return product analysis showed damage to several electrodes.The damage of the electrodes showed visual inspection stretching, twisting on the brain end, and kinking on the body of the electrode.Digital testing of the electrodes confirmed the customers complaint.A root cause cannot be determined.The evidence of the product damage makes it difficult to determine the cause of a failure.These instances typically occur when there is a forceful tug on the electrodes during a seizure, patient movement, electrode/cable manipulation, etc.The risk assessment concluded that the resulting risk level remains "acceptable" and no further action is needed at this time.

Event Description

On march 2, 2023, ad-tech's customer support manager was contacted via email, by a customer stating that twelve (12) depth electrodes were placed in a patient on (b)(6) 2023.The patient was then brought back into surgery on post op day 3 to have eight (8) electrodes replaced on (b)(6) 2023 due to increasing artifact on the eeg.There was no injury to the patient, however a second surgery was needed for replacement of electrodes.On march 23, 2023, fda sent ad-tech the associated user facility report (b)(4), which had been submitted by the customer.

• Brand Name: SPENCER PROBE DEPTH ELECTRODE
• Type of Device: 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: 16652791
• MDR Text Key: 312532121
• Report Number: 2183456-2023-00005
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823107695
• UDI-Public: (01)00841823107695(17)240601(10)01556088807808809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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 Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: SD08R-SP05X-000
• Device Catalogue Number: SD08R-SP05X-000
• Device Lot Number: 0156088807808809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1