• 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 SMALL ACTIVE CRANIAL FRAME LONG CABLE INSTRUMENT, STEREOTAXIC

  • 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 SMALL ACTIVE CRANIAL FRAME LONG CABLE INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733881
Device Problems Material Integrity Problem (2978); Output Problem (3005)
Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure. The information received was contradicting and we are following up to confirm the information. It was reported that one of the led lights had a recognition failure. The procedure was completed with the continuous use of the frame. The site was able to complete the procedure with the use of the frame. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Analysis on the returned active frame resulted in an electrical failure being found through functional testing and visual/physical examination. Analysis states that, when connected to a known good system, it was found that led #3 was not firing. Otherwise, the frame returned good geometry and divot error readings. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: patient information was unavailable. Additional information: updated event description. Additional information: fda patient code has been updated to proper value. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was clarified that this issue occurred during a craniotomy procedure. It was noted that the active reference frame could be used for the time being even though one led did not recognize. There was no surgical delay due to this issue. There was no known or reported impact on patient outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSMALL ACTIVE CRANIAL FRAME LONG CABLE
Type of DeviceINSTRUMENT, STEREOTAXIC
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8175256
MDR Text Key130691454
Report Number1723170-2018-06336
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733881
Device Catalogue Number9733881
Device Lot Number140812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-