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

Model Number 2102-XX-091

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information provided to the pmt sales rep, verbally and through notes taken by the sales rep.The seeg depthalon depth electrode was not the problem.The attending doctor told the pmt sales rep that the resident performing the drilling process during the procedure drilled through the pmt electrode.The resident told his pmt sales rep himself that he believed he drilled through the electrode.Request for further specific information went unanswered.Specifically reaching out to the initial reporter of the medwatch.The pmt sales rep didn't contact corporate to initiate a complaint file because the doctor and resident confirmed that it was not a pmt product problem.

Event Description

Per the medwatch received via email from the fda on 1/3/2024 the following occured: "patient underwent removal of stereo eeg leads.Post-operative imaging demonstrated retained fractured portion which required return to operating room for removal.Ref report# mw5149265.".

• Brand Name: SEEG DEPTHALON DEPTH ELECTRODE
• Type of Device: 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: 18778285
• MDR Text Key: 336219822
• Report Number: 2182979-2024-00001
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2024

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 Model Number: 2102-XX-091
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1