MAUDE Adverse Event Report: AD - TECH MEDICAL INSTRUMENT CORP. MACRO-DEPTH ELECTRODE, 8-CONTACT; ELECTRODE, DEPTH

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2023

Event Type  Injury  

Event Description

Patient underwent removal of stereo eeg leads.Post-operative imaging demonstrated retained fractured portion which required return to operating room for removal.Ref report: mw5149266.

• Brand Name: MACRO-DEPTH ELECTRODE, 8-CONTACT
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): AD - TECH MEDICAL INSTRUMENT CORP.; oak creek WI 01568 90
• MDR Report Key: 18334345
• MDR Text Key: 330855432
• Report Number: MW5149265
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic