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

Model Number	FC2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent implantation of the deep brain stimulator (dbs) to left gpi for dystonia.Five years ago they were implanted bilaterally stn for parkinson's disease.The procedure was commenced as per usual, burr hole performed mer.Nothing was noted to be unusual.Intra-operative xrays performed.On removal small amounts of blood in mer cannula were observed.The lead was implanted and an x-ray was performed.Leads from previous implant observed that one was displaced.Curvature was evident.A ct was performed and a large basal ganglia haematoma was evident with a mid line shift.The patient returned to the operating room and a emergency ventricular catheter was inserted and external ventricular drain was attached.Csf was drained.No obvious blood staining evident.Both pupils were reactive and the patient remains intubated.They were transferred to the intensive care unit.The issue is not yet resolved.Additional information was received reporting that the hematoma was attributed to the insertion of the mer electrode which is believed to have ruptured a vessel, causing the bleed; and therefore the swelling from hematoma impact the installed lead causing it to displaced.A ct was performed a large basal ganglia hematoma was evident with a mid line shift, the patient returned to the operation room and the emergency ventricular catheter was inserted and external ventricular drain attached.Csf was drained and no obvious blood staining was evident.The patient remained intubated and was transferred to the icu.The continue to have daily ct's which have shown that the haematoma has not increased in size.They have not received detailed information on the medications prescribed except that a standard protocol for haematoma, haemorrhage was provided.The patient is breathing unassisted, tube remains and swallowing needs to be assessed before removal.They responded to simple commands such as hand squeezes and eye blinks.The patient has been discharged from the icu, and transferred to a ward.This was confirmed with the physician.

• Brand Name: FHC MICROELECTRODE
• Common Device Name: DEPTH ELECTRODE
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin, me
• MDR Report Key: 10425577
• Report Number: 3002250546-2020-00002
• Device Sequence Number: 14166703
• Product Code: GZL
• UDI-Device Identifier: 10873263007508
• UDI-Public: 10873263007508
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: FC2002
• Device Catalogue Number: FC2002
• Device Lot Number: 244447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR