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

Model Number GUIDELINE 4000 5.0 SYSTEM

Device Problem Energy Output Problem (1431)

Patient Problem Paresthesia (4421)

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

System was returned to fhc for evaluation.Evaluation could not determine the cause of the issue in the field.

Event Description

On (b)(6) 2022 during a unilateral dbs case it was reported that the patient experienced very strong contractions on his hand when macro-stimulating with constant current 0.25 ma on central and lateral tracks.Stimulation was immediately turned off.Stimulation was tried again and the system showed a malfunction message and shut down.In that moment, the patient felt a strong stimulation again.The electrode impedance was 900 and the recordings on both tracks were good.The output voltage was not noted.Physician requested to disconnect the electrode cables and implanted the dbs lead to macro-stimulate with it.When stimulating with the lead, no adverse effects were reported.Patient recovered his arm movement once the stimulation with the gl5 stopped.Surgery was successfully completed.The patient had his first lead implanted a year ago.This was the second side (right).

• 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: 14582420
• MDR Text Key: 301918154
• Report Number: 3002250546-2022-00001
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2022

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: GUIDELINE 4000 5.0 SYSTEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 06/02/2022
• 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): Hospitalization
• Patient Sex: Male