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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE PLANAR BLUNT PROBE INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC PASSIVE PLANAR BLUNT PROBE INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-556
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
Patient weight not available. Device lot number unavailable. Udi not available. A manufacturer representative went to the site to test the navigation system. While on-site, it was discovered that the passive planar blunt had a bent post. It was still possible to register the probe using four spheres instead of five. Device manufacturing date unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a cranial resection. It was reported that intra-operatively, the surgeon was having issues registering a patient because the non-sterile passive planar was having tracking issues. The instrument was flickering while tracking. The site switched spheres, tried a new probe, and removed and re-added the probe into the software without resolution. Technical services (ts) was contacted for troubleshooting and confirmed that there were no other instruments in view of the camera and the frame was being tracked fine. Ts recommended covering the spheres on the instrument on at a time to see if allowed the instrument to track without the issue. After doing so, the surgeon stated with one of the spheres covered, the instrument was tracking, so ts recommended removing that sphere from the post. The surgeon then re-registered with a passing metric and was able to move forward with the case. The procedure was completed using the navigation system and there was no reported impact to patient outcome. There was a reported delay to the procedure of an hour or longer due to this issue.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePASSIVE PLANAR BLUNT PROBE
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 Key9434146
MDR Text Key183091998
Report Number1723170-2019-05902
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number960-556
Device Catalogue Number960-556
Device Lot Number180404
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 Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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