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

Model Number	FC2001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subdural (1894)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
Product used: fc2001, lot # 221236 - microtargeting electrode.During the use of the microtargeting electrode on (b)(6) 2016, the patient had a cerebral hemorrhage.Event was described as follows: after a lead was positioned in the right side, miniature potential in the left side was measured.Multi-technique method was conducted, and 2 tracks of center and postero were recorded.Waves could not be confirmed at depth of stn target (stn waves seemed to appear partly but were unstable).Sn waves seemed to be identified at plus 1.5mm to 5 mm on the postero side.Tracks were changed to latte and antelo to measure again.Although impedance declined at 1200 ohms on latte side and around 700 ohms on antelo side, the procedure was continued.At re-measurement, even small typical background waves were identified.The patient experienced motor function and consciousness level in depression on the left side of the body.The procedure was aborted.Ct scan images identified cerebral hemorrhage.The patient was placed under monitoring the customer did not consider that the reported product caused the event issue.

• Brand Name: MICROTARGETING ELECTRODE
• Common Device Name: DEPTH ELECTRODE
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• MDR Report Key: 6128176
• Report Number: 3002250546-2016-00003
• Device Sequence Number: 255321
• Product Code: GZL
• UDI-Device Identifier: 10873263001261
• UDI-Public: 10873263001261
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K033173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2016

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: 05/31/2019
• Device Model Number: FC2001
• Device Lot Number: 221236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 11/27/2016
• 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