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

Catalog Number WB09R-SP00X-0B6/BF09R-SP16X-0B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fungal Infection (2419)

Event Date 10/24/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 it was reported that a patient who had intercranial monitoring unfortunately developed a post-operative fungal infection.

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 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.

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.

• Brand Name: DEPTH ELECTRODE
• Type of Device: 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
• MDR Text Key: 329625311
• Report Number: 2183456-2023-00009
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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?: No
• 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
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other