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

Model Number	SD08R-SP05X-000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During explant, a depth electrode fragment was retained.Extra imaging and unplanned procedures were necessary to remove the fragment.There was no patient harm.
Additional Manufacturer Narrative
Complainant reported that the depth electrode was severed (broken in two) where it looked like the electrode broke at the end of the anchor bolt.It was discovered during explant when only part of the electrode came out.An additional scan was completed to ensure that the remaining part of the electrode was intact and that contacts or wires were not additionally separated from the remaining portion of the depth.Once they confirmed that the electrode only split into two parts, the remaining portion of the depth which was sticking out of the dura was removed with a micrograsper.Complainant stated that this only added an additional 20 minutes to the procedure and the patient was released next day (standard procedure).This patient was reported to having had extremely violent seizures during monitoring.No specific information regarding the electrode catalog number, lot, or batch has been received by the user facility.The electrode has not yet been returned.
Additional Manufacturer Narrative
Complainant reported that the depth electrode was severed (broken in two) where it looked like the electrode broke at the end of the anchor bolt.It was discovered during explant when only part of the electrode came out.An additional scan was completed to ensure that the remaining part of the electrode was intact and that contacts or wires were not additionally separated from the remaining portion of the depth.Once they confirmed that the electrode only split into two parts, the remaining portion of the depth which was sticking out of the dura was removed with a micrograsper.Complainant stated that this only added an additional 20 minutes to the procedure and the patient was released next day (standard procedure).This patient was reported to having had extremely violent seizures during monitoring.No specific information regarding the electrode catalog number, lot, or batch has been recieved by the user facility.The electrode has not yet been returned.Updated 11/16/2022.The break in the electrode occurred between the 7th and 8th contact on the brain end.The 8th contact was crushed and severely damaged in the tubing at the break location, and the anchor bolt cap was attached to the electrode at the damaged 8th contact.The complaintant stated that the patient had extremely violent seizures and the trajectory was very high on the head at an oblique angle.The most likely cause would have been the electrode rubbing against the bolt thread due to how it was placed.The risk assessment concluded that the occurence level is "alap" (as low as possible).
Event or Problem Description
During explant, a depth electrode fragment was retained.Extra imaging and unplanned procedures were necessary to remove the fragment.There was no patient harm.

• Brand Name: SPENCER DEPTH ELECTRODE
• Common Device Name: 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: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 14414105
• Report Number: 2183456-2022-00013
• Device Sequence Number: 5499954
• Product Code: GZL
• UDI-Device Identifier: 00841823107695
• UDI-Public: (01)00841823107695(17)231001(10)0149657780781782
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: SD08R-SP05X-000
• Device Catalogue Number: SD08R-SP05X-000
• Device Lot Number: 780781782
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown