MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTEM; GUIDELINE 5

Model Number GUIDELINE 4000 5.0 SYSTEM

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

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/09/2024

Event Type  malfunction  

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 Description

On (b)(6) 2023, an adverse event occurred with the guideline 5 (gl5).The gl5's ue interface c0219: sn (b)(6) failed the self-test during power on initialization due to a loss of connectivity which occurred during the self-test.The medical staff at the facility clicked through the failed self-test pop-up dialog warning.Macro-stimulation was performed.The patient had a strong reaction elevating and posturing.Stimulation was immediately discontinued.Stimulation current was adjusted to 0.0 ma and briefly reapplied.Patient's reaction was similar to the previous result.The medical staff replaced the microelectrode with the dbs lead and applied stimulation via the dbs company's test stimulator and the case was completed.The dr.Reports the patient is fine, no lasting effects.The product was returned to fhc,inc.For evaluation, we have been unable to recreate the issues described.

• Brand Name: MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTEM
• Type of Device: GUIDELINE 5
• 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: 18875707
• MDR Text Key: 337862343
• Report Number: 3002250546-2024-00001
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GUIDELINE 4000 5.0 SYSTEM
• Device Catalogue Number: C0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Date Manufacturer Received: 02/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose