MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTE; 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 02/22/2023

Event Type  malfunction  

Event Description

On the morning of (b)(6)2023, an adverse event occurred with the guideline 5 (gl5).The gl5's ue interface c0219: sn(b)(4) 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.A single mtd electrode was used on the center track for the case.Macro-stimulation was performed.The patient had a sudden muscle contraction of the right face pulling and the right arm elevating and posturing (fingers and wrist flexed) that was painful.Stimulation was immediately discontinued.Stimulation current was adjusted to 0.1ma and briefly reapplied.Patient's reaction was similar to the previous result.The stimulation mode was changed within the stimulation dialog from constant current to constant voltage which elicited a third patient reaction.Stimulation was discontinued.Electrode and patient lead were replaced for the second side.Out of caution no stimulation was performed on the second side.The case was completed without problems fhc,inc.Has been unable to recreate the issues described on in-stock units, a review of the customer unit will be conducted upon return to our facility.

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¿ GUIDELINE 4000¿ 5.0 SYSTE
• 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: 16552365
• MDR Text Key: 311389929
• Report Number: 3002250546-2023-00001
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other