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

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM NEUROLOGICAL 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
 

MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735665
Device Problems Mechanical Problem (1384); Output Problem (3005)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 09/22/2021
Event Type  Injury  
Manufacturer Narrative
The neuro accessory kit was returned to the manufacturer for analysis. The kit was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. Other relevant device(s) are: product id: 29631, serial/lot #: (b)(4), udi#: (b)(4); product id: 9735571, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system and automated trajectory guidance unit being used during a catheter placement for a medtronic thermal therapy system procedure. It was reported that there were difficulties placing the bone anchor. It was reported that after alignment with the guidance unit and drilling a burr hole, the bone anchor was not "smooth". It was noted that there were difficulties with alignment of the guidance unit as well. A second burr hole was attempted, but it was noted that the hole was overburred. It was reported that the drape around the guidance unit did not interfere with the guidance unit and that the unit pressed against the mayfield in the room. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTHSTATION S8 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12624377
MDR Text Key276166481
Report Number1723170-2021-02493
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
-
-