MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ ELECTRODE

Model Number	44975Z-00267
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	01/02/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
A case was completed on (b)(6) 2025 at (b)(6) medical center, (b)(6) with dr.(b)(6), where a 57 y/o patient had boston scientific leads implanted bilaterally in stn.Mer was performed on both hemispheres simultaneously using fhc 44975z microelectrodes (a single track per side) and a guideline 4000 lp+ system.Other fhc products used during the case were starfix platform, 66-it-03p insertion tubes, 66-st-12p stylet.Patient responded well to stimulation and o-arm imaging showed accurate targeting.Post-op ct showed no abnormalities and patient was discharged the same day of surgery.The patient was doing well and had gone back to work.Facility did not retain lot# of product used and disposed of products.On 01/16/2025 fhc, inc.Representative was attending another case at (b)(6) medical center with dr.(b)(6) where during the case, the dr.Informed the fhc rep, that the patient they operated on (b)(6) 2025 was found dead this week and that they were going to conduct an autopsy to determine the cause of death.The autopsy was conducted on (b)(6) 2025 where an intracerebral hemorrhage (ich) at dbs-lead entry site and thalamus was determined to be cause of death.Since post-op ct was clear, it was considered a delayed ich.

• Brand Name: MICROTARGETING¿ ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: kelly moeykens ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 21295201
• Report Number: 3002250546-2025-00001
• Device Sequence Number: 9245468
• Product Code: GZL
• UDI-Device Identifier: 00873263002674
• UDI-Public: 00873263002674
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K033173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: 44975Z-00267
• Device Catalogue Number: 44975Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Age: 57 YR
• Patient Sex: Male