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

Catalog Number TBD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/05/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 after the placement of depth electrodes, a hemorrhage was found on the post-op scan.

Manufacturer Narrative

This report was past the 30-day date of awareness due to it was discovered from a customer survey and was not processed until 11-30-2023.Dr.(b)(6) was interviewed on 12/7/2023 about the reported hemorrhage.The investigation results revealed the root cause of the hemorrhage was not caused by the use of the depth electrodes, but rather due to the planning of surgical trajectories.

Event Description

On (b)(6) 2023 after the placement of depth electrodes, a hemmorhage was found on the post-op scan.

Manufacturer Narrative

This report was past the 30-day date of awareness due to it was discovered from a customer survey and was not processed until 11-30-2023.Dr.(b)(6) was interviewed on (b)(6) 2023 about the reported hemorrhage.The investigation results revealed the root cause of the hemorrhage was not caused by the use of the depth electrodes, but rather due to the planning of surgical trajectories.Updated 01/02/2024 the customer stated there was no lasting impact on the patient;.Our internal investigation concluded our devices were not the cause of the hemmorhage and performed as intended.No specific catalog numbers, lot, or batches were identified.In addition, no product was available for return.The doctor associated with this case stated that ad-tech's devices did not cause the deficiency, that the deficiency was caused by planning of surgical trajectories.No further actions are needed at this time.

• 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: 18347416
• MDR Text Key: 330740965
• Report Number: 2183456-2023-00012
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• 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