MAUDE Adverse Event Report: PMT CORP. ELECTRODE STYLET; ELECTRODE, DEPTH

Model Number 2102-08-091

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Upon removal from patient, electrode piece was retained in patient's temporal lobe.Unable to remove due to risk at this time.

• Brand Name: ELECTRODE STYLET
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): PMT CORP.
• MDR Report Key: 18930898
• MDR Text Key: 338146934
• Report Number: MW5152958
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2102-08-091
• Device Catalogue Number: 2102-08-091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White