MAUDE Adverse Event Report: PMT CORPORATION 1500 PARK ROAD, CHANHASSEN, MN USA SEEG ELECTRODE LEAD (MANUFACTURED BY PMT CORPORATION); ELECTRODE, DEPTH

Device Problems Structural Problem (2506); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2016

Event Type  malfunction  

Event Description

A medtronic representative initially reported that during a cranial electrode and probe placement procedure after using the passive catheter introducer (pci) tip probe to create a channel for the electrode the surgeon was not happy with where the electrode was placed.Later it was clarified that the surgeon placed four electrodes after navigating the pci probe to create the channel and felt like two electrodes were off from where they needed to be.There was no alleged deficiency with a medtronic product.The navigation equipment and instrumentation were confirmed to be fully functional.Per discussion with the surgeon, the reason for the lead misplacement was that they were trying to navigate a third party seeg electrode lead (mfr by pmt) which was "flimsy" and not designed for navigation.They x-rayed the patient on the table to confirm lead placement.The surgeon did not specify an amount that the lead was off.Although the placement was not perfect, they did not revise or change the placement of the lead as it was satisfactory for therapeutic use.There was no reported impact to the outcome of the patient.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SEEG ELECTRODE LEAD (MANUFACTURED BY PMT CORPORATION)
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): PMT CORPORATION 1500 PARK ROAD, CHANHASSEN, MN USA
• MDR Report Key: 17535083
• MDR Text Key: 321521292
• Report Number: MW5141983
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2016

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1