• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FHC, INC, STAR DRIVE STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FC8001
Device Problems Malposition of Device (2616); Activation, Positioning or SeparationProblem (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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTAR DRIVE
Type of DeviceSTEREOTAXIC 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 Key8946872
MDR Text Key203710449
Report Number3002250546-2019-00004
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K092562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFC8001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/29/2019 Patient Sequence Number: 1
-
-