MAUDE Adverse Event Report: FHC, INC, FHC MICROELECTRODE; DEPTH ELECTRODE

Model Number 44975Z

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)

Event Date 02/25/2019

Event Type  Death  

Event Description

Procedure - staged bi-lateral dbs procedure.The first surgery was performed (one side of a bi-lateral procedure).The patient was sent home (planned) and was to come back and do the second surgery.Fhc emailed to check on when the second surgery was going to be scheduled and the hospital administrative person said the second surgery was canceled because the patient passed away.The surgeon noted that the surgery went great, the patient was fine after surgery and went home the next day and had a delayed hemorrhage and passed away.

Manufacturer Narrative

Device was not returned for evaluation.No indication of device malfunction.Microelectrode recording (mer) involves the use of sterile metal probes which are inserted into the brain during surgery.This may cause hemorrhage with a know adverse effect rate of (b)(4).

Manufacturer Narrative

Report type changed from a 5 day to an initial 30 day.This is based on telephone conversation between fda and kelly moeykens (fhc) on 3/5/2019.

• Brand Name: FHC MICROELECTRODE
• Type of Device: DEPTH ELECTRODE
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• MDR Report Key: 8388293
• MDR Text Key: 137874914
• Report Number: 3002250546-2019-00002
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• PMA/PMN Number: K033173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2019

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: 44975Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 02/25/2019; 02/25/2019
• Supplement Dates FDA Received: 03/05/2019; 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 66-IT-AR4P - FHC INSERTION TUBE; 70-IT-AR5P - FHC INSERTION TUBE; BILATERAL DBS PLATFORM: SN (B)(4); LP+: 31427 -; MTC: SN (B)(4); STAR DRIVE: SN (B)(4) - FHC DRIVE SYSTEM
• Patient Outcome(s): Death
• Patient Age: 71 YR