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

Model Number FC8001

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem Facial Nerve Paralysis (1846)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

This report was originally submitted on 05/20/19 but due to a technical error, it did not upload.

Event 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
• Type of Device: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC,; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: craig pagan ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 8946872
• MDR Text Key: 203710449
• Report Number: 3002250546-2019-00004
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00873263001486
• UDI-Public: 00873263001486
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FC8001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR