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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Communication or Transmission Problem (2896); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
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 procedure. It was reported that during the case, the surgeon was unable to verify the passive planar probe. The system was displaying a high distance to divot value, and the spheres were flickering in the tracking view. The site swapped to a new passive planar probe, new spheres, and a new cranial frame and the issue did not resolve. The probe was unable to be verified and the site swapped to electromagnetic navigation to continue the case with the system. There was a 2 hour delay to the procedure and no impact to patient outcome as a result of this issue.
 
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Brand NameSTEALTHSTATION S7
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 Key10059636
MDR Text Key191082101
Report Number1723170-2020-01434
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
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 Received05/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2010
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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