MAUDE Adverse Event Report: FHC, INC. MT ELECTRODE & TUBES; DEPTH ELECTRODE

Model Number	FC2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Speech Disorder (4415)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event involving fhc mt electrode & tubes occurred during a case on (b)(6) 2020.The event was described as follows: after single pass mer the surgeon advanced the microelectrode to the vim target and the patient began to slur his speech.There was no stimulation running at the time.Hcps decided to discontinue with plan to test stim and removed the micro electrode and implanted a 3387.The issue was not with the device, it was just the device that was being used at the time the issue occurred.Patient was conscious and able to talk, but had slurred speech a the end of the procedure.Possible stun effect.Patient update: the patient still has slightly slurred speech but is improving.This has been confirmed with the physician.".

• Brand Name: MT ELECTRODE & TUBES
• Common Device Name: DEPTH ELECTRODE
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• MDR Report Key: 10676753
• Report Number: 3002250546-2020-00004
• Device Sequence Number: 3025931
• Product Code: GZL
• UDI-Device Identifier: 10873263007508
• UDI-Public: 10873263007508
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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 Expiration Date: 08/20/2022
• Device Model Number: FC2002
• Device Catalogue Number: FC2002
• Device Lot Number: 244446
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other