MAUDE Adverse Event Report: DIXI MEDICAL; ELECTRODE, DEPTH

Model Number MICRODEEP DEPTH ELECTRODE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2022

Event Type  Injury  

Event Description

Patient with a history of medically refractory epilepsy went to the operating room (or) for a bilateral stereotactic depth electrode placement to monitor seizures.A total of eight electrodes were placed on the left and one electrode on the right.Neurosurgery removed a right lateral loose lead during rounds and covered the area with 3m steri-strip skin closures.Patient went to the or for removal of left-sided dixi seeg depth electrodes and bolts and a left-sided craniotomy for placement of pmt subdural grid and strip electrodes.Eight left electrodes were removed.Patient went for a ct which showed a partially retained right electrode and left electrode.Patient went back to the or for a right-sided burr hole to remove the retained stereoelectroencephalography dixi depth electrode.The retained left electrode is under the subdural grid that was placed and will be removed at the same time the grid is removed, the date for this has not yet been determined.Thought is that the electrodes broke after patient had a violent seizure.

Event Description

Patient with a history of medically refractory epilepsy went to the operating room (or) for a bilateral stereotactic depth electrode placement to monitor seizures.A total of eight electrodes were placed on the left and one electrode on the right.Neurosurgery removed a right lateral loose lead during rounds and covered the area with 3m steri-strip skin closures.Patient went to the or for removal of left-sided dixi seeg depth electrodes and bolts and a left-sided craniotomy for placement of pmt subdural grid and strip electrodes.Eight left electrodes were removed.Patient went for a ct which showed a partially retained right electrode and left electrode.Patient went back to the or for a right-sided burr hole to remove the retained stereoelectroencephalography dixi depth electrode.The retained left electrode is under the subdural grid that was placed and will be removed at the same time the grid is removed, the date for this has not yet been determined.Thought is that the electrodes broke after patient had a violent seizure.

Event Description

Patient with a history of medically refractory epilepsy went to the operating room (or) for a bilateral stereotactic depth electrode placement to monitor seizures.A total of eight electrodes were placed on the left and one electrode on the right.Neurosurgery removed a right lateral loose lead during rounds and covered the area with skin closures.Patient went to the or for removal of left-sided dixi seeg depth electrodes and bolts and a left-sided craniotomy for placement of a subdural grid and strip electrodes.Eight left electrodes were removed.Patient went for a ct which showed a partially retained right electrode and left electrode.Patient went back to the or for a right-sided burr hole to remove the retained stereoelectroencephalography dixi depth electrode.The retained left electrode is under the subdural grid that was placed and will be removed at the same time the grid is removed, the date for this has not yet been determined.Thought is that the electrodes broke after patient had a violent seizure.

• Brand Name: NA
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): DIXI MEDICAL; 11910 fox ridge drive; plymouth MI 48170
• MDR Report Key: 16120456
• MDR Text Key: 306895462
• Report Number: 16120456
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2023

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?: Yes
• Device Model Number: MICRODEEP DEPTH ELECTRODE
• Device Catalogue Number: D08-12AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2023; 01/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 12045 DA
• Patient Sex: Male