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

Model Number C0215

Device Problem Output Problem (3005)

Patient Problem Paresthesia (4421)

Event Date 06/24/2021

Event Type  Injury  

Event Description

During a bi-lateral dbs case with an fhc loaner gl5 it was reported that the patient was experiencing adverse effects, paresthesia's, when performing macro-stimulation with constant current 1ma reading 6v.He confirmed the patient was properly grounded.He decreased the ma and the patient was still seeing adverse effects.He performed a gl5 self-test before switching to the other hemisphere.The self-test indicated all channels failed.After a reboot, the self-test was performed showing all channels passed.While using macro-stimulation on the other hemisphere, similar paresthesia's were reported.When testing with the lead, no adverse effects were reported.No delay to surgery and no patient harm.He also clarified the stimulation settings stating that the constant current starting at 0.5 ma.Did not see voltage at that level given the patient's strong reaction.Immediately turned off stimulation.Turned ma to 0.When stimulation turned on at this level, patient still had strong reaction.Saw that display was reading ~ 6 v/0ma.Surgery was successfully completed.

• 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: 12201992
• MDR Text Key: 262624969
• Report Number: 3002250546-2021-00003
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2021

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
• Device Operator: Health Professional
• Device Model Number: C0215
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other