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

Model Number 2103

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2015

Event Type  No Answer Provided  

Event Description

Stereoelectroencephalography (seeg) leads were placed in early 2015 and removed 9 days later.After removal, an intra-operative x-ray showed several tiny metallic fragments near the skull base.This electrode tip was removed during an already-planned secondary surgery.

• Brand Name: DEPTHALON
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): PMT CORP.; 1500 park rd.; chanhassen MN 55317
• MDR Report Key: 4770804
• MDR Text Key: 5791136
• Report Number: 4770804
• Device Sequence Number: 0
• Product Code: GZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Device Operator: Invalid Data
• Device Model Number: 2103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Age: 53 YR
• Patient Weight: 73