MAUDE Adverse Event Report: PMT CORPORATION PMT DEPTHALON DEPTH ELECTRODE; SEEG DEPTH ELECTRODE

Model Number	2102-14-091
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the bullet tip that was removed from the patient was returned.The remainder of the electrode was discraded by the user.Investigation findings/results: the tracer sheet had no abnormalities or rejects associated with this lot and model.All electrodes on the tracer fully passed qc inspection.The bullet-tip contact was physically examined and there are no obvious signs of damage to the contact itself.There is no way for pmt to determine exactly how the contact pulled off of the electrode, but it is clear that it happened based on the customer report.Investigation conclusion/cause of problem: all seeg electrodes are 100% inspected and because the electrode passed qc inspection, there was no manufacturing issue with the electrode itself.For the bullet-tip contact to come off and get left behind in a patient, it is likely that an excessive force was applied to the electrode at some point during placement, while implanted, or during removal.The depthalon manual states to handle the electrodes with extreme care to avoid damage.
Event or Problem Description
The doctor placed the electrode ((b)(6) 2024) and when tested, the #1 contact was not reading the electrode was replaced right away.When the post op scan was performed on (b)(6) 2024, the #1 contact was still in the patients head.Another surgery was performed to remove the fragment that was left behind.He made an incision and a small burr hole to retreived the contact on (b)(6) 2024.

• Brand Name: PMT DEPTHALON DEPTH ELECTRODE
• Common Device Name: SEEG DEPTH ELECTRODE
• Manufacturer (Section D): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer (Section G): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer Contact: kim schmelzer ; 1500 park road; chanhassen, MN 55317 ; 9524700866
• MDR Report Key: 19651894
• Report Number: 2182979-2024-00002
• Device Sequence Number: 15165695
• Product Code: GZL
• UDI-Device Identifier: 00650551041696
• UDI-Public: 00650551041696
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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 Model Number: 2102-14-091
• Device Catalogue Number: 2102-14-091
• Device Lot Number: 092623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown