MAUDE Adverse Event Report: FHC, INC, STAR DRIVE; STEREOTAXIC INSTRUMENT

Model Number	FC8001
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Facial Nerve Paralysis (1846)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was originally submitted on 05/20/19 but due to a technical error, it did not upload.
Event or Problem Description
Information was received from medtronic - distributor of product, regarding a patient with an implantable neurostimulator (ins).It was reported that during implant of the patient's right lead, the stardrive tower was not attached to the stardrive body to hold the dbs lead at the correct target.As a result, the depth stop was placed on the drive incorrectly and the lead traveled deeper than desired.The error was discovered and the lead was placed on the tower correctly and the lead location was confirmed correct with a ct scan.It was noted the surgical team was inexperienced and missed a step to place the tower on the stardrive.The rep also noted they themselves failed to recognize the step was missed.The issue was resolved.It was noted the patient experienced right eye six nerve palsy; their recovery was to be monitored over the next six months.No further complications were reported as a result of this event.

• Brand Name: STAR DRIVE
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• MDR Report Key: 8946872
• Report Number: 3002250546-2019-00004
• Device Sequence Number: 19602872
• Product Code: HAW
• UDI-Device Identifier: 00873263001486
• UDI-Public: 00873263001486
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FC8001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 08/29/2019
• 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: Other
• Patient Age: 48 YR