MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. MICRO DEPTH ELECTRODE; MACRO DEPTH ELECTRODE

Model Number	WB09R-SP00X-0B6;BF09R-SP16X-0B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 it was reported that a patient who had intercranial monitoring unfortunately developed a post-operative fungal infection.
Additional Manufacturer Narrative
At the time of the this report, we have insufficient information to conduct an investigation.We have sent follow-up questions to the client that are pertinent in the progression of our investigation.Once new information is provided a follow-up report will be filed.
Event or Problem Description
On (b)(6) 2023 it was reported that a patient who had intercranial monitoring unfortunately developed a post-operative fungal infection.Updated 01/31/2024.The customer provided more information after filing the initial report, the incident date was 10/24/2023.
Additional Manufacturer Narrative
At the time of the this report, we have insufficient information to conduct an investigation.We have sent follow-up questions to the client that are pertinent in the progression of our investigation.Once new information is provided a follow-up report will be filed.Updated 02/01/2024.The electrodes were implanted on (b)(6) 2023 and monitored for 12 days.There was external evidence of infection of the skin around 3 electrodes at the time of explantation on (b)(6) 2023.This was associated with fevers and raised serum inflammatory markers.This led to an extended hospital stay for the patient and protracted treatment with anti-microbials (antifungal) medication.There was no long term neurological sequalae.
Event or Problem Description
On 11/09/2023 it was reported that a patient who had intercranial monitoring unfortunately developed a post-operative fungal infection.Updated 01/31/2024: the customer provided more information after filing the initial report, the incident date was (b)(6) 2023.
Additional Manufacturer Narrative
At the time of the this report, we have insufficient information to conduct an investigation.We have sent follow-up questions to the client that are pertinent in the progression of our investigation.Once new information is provided a follow-up report will be filed.Updated 02/01/2024: the electrodes were implanted on (b)(6) 2023 and monitored for 12 days.There was external evidence of infection of the skin around 3 electrodes at the time of explantation on (b)(6) 2023.This was associated with fevers and raised serum inflammatory markers.This led to an extended hospital stay for the patient and protracted treatment with anti-microbials (antifungal) medication.There was no long term neurological sequelae."udi related data quality updates only".Updated 09/20/2024: clarification and correction of the following missing items from previous supplemental report: brand name- micro depth electrode; macro depth electrode, model and catalog number wb09r-sp00x-0b6; bf09r-sp16x-0bb.Primary di numbers: (b)(4).

• Brand Name: MICRO DEPTH ELECTRODE; MACRO DEPTH ELECTRODE
• Common Device Name: MICRO DEPTH ELECTRODE; MACRO 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: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 18258481
• Report Number: 2183456-2023-00009
• Device Sequence Number: 19854503
• Product Code: GZL
• UDI-Device Identifier: 00841823108432
• UDI-Public: 841823108432
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: WB09R-SP00X-0B6;BF09R-SP16X-0B
• Device Catalogue Number: WB09R-SP00X-0B6;BF09R-SP16X-0B
• Device Lot Number: 804805806;783784785
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 11/10/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/01/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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