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

Model Number	FC2001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
When mer on one side was completed and a test stimulation was used, it was confirmed that the left side of the body opposite to the right hemisphere where mer was performed could not be moved as the patient wanted it to.The patient's response was not clear and the patient's condition was strange, so a dbs operation was discontinued, and when a ct scan was performed; a hemorrhage in the brain was confirmed.Subsequently, the blood was removed via emergency craniotomy.The progress has not been confirmed yet.The product was discarded and lot number is unknown.The doctor has confirmed there was no issue with our product, this happens as a side effect of brain surgery.
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.

• Brand Name: MICROTARGETING¿ ELECTRODE
• Common Device Name: DEPTH 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: 18245509
• Report Number: 3002250546-2023-00003
• Device Sequence Number: 20598019
• Product Code: GZL
• UDI-Device Identifier: 10873263007492
• UDI-Public: 10873263007492
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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: FC2001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Other
• Patient Sex: Unknown