MAUDE Adverse Event Report: PMT CORPORATION DEPTHALON DEPTH ELECTRODE; SEEG DEPTHALON DEPTH ELECTRODE

Model Number 2102-08-091

Device Problem Separation Problem (4043)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint received identified that a fragment of the electrode was left behind in the patient after the electrode was removed.After visual inspection of the returned product, it is clear that the electrode tubing sheared between the third and fourth contacts.This likely occurred due to the force applied when pulling the electrode out.The information provided about the electrode not going in smoothly indicates that the electrode may have been off angle slightly, and because of that, when it was pulled out it may have caught on the anchor bolt which could have caused the electrode to break.

Event Description

Email received from doctor on november 10, 2023.I want to open a "ticket" for the company to review the case we had last week where the electrode got torn.There is a tiny fragment (the tip) that is stuck in the motor cortex so i cannot pull it out.We are still trying to figure out if the patient can have an mri (i believe he can but we are trying to understand) and also what can be the reason.I talked to several friends that are quite experienced with seeg working with pmt electrodes and none had this issue.I myself did at least 50 cases with pmt and more than 500 electrodes and never had this issue.

• Brand Name: DEPTHALON DEPTH ELECTRODE
• Type of Device: SEEG DEPTHALON DEPTH ELECTRODE
• Manufacturer (Section D): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer (Section G): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer Contact: kim schmelzer ; 1500 park road; chanhassen, MN 55317
• MDR Report Key: 18617662
• MDR Text Key: 335088670
• Report Number: 2182979-2023-00001
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00650551041634
• UDI-Public: 0650551041634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2023

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 Operator: Health Professional
• Device Model Number: 2102-08-091
• Device Catalogue Number: 2102-08-091
• Device Lot Number: 072123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2023
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention