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

Model Number FC2002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Speech Disorder (4415)

Event Date 09/18/2020

Event Type  Injury  

Event 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
• Type of Device: 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: 10676753
• MDR Text Key: 211243238
• Report Number: 3002250546-2020-00004
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 10873263007508
• UDI-Public: 10873263007508
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: FC2002
• Device Catalogue Number: FC2002
• Device Lot Number: 244446
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other