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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Computer Software Problem (1112); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9733763, software version (b)(4). A software analysis was initiated to determine the probable cause of the issue through review of the reported issue. Analysis found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used during a transsphenoidal procedure. It was reported that after verifying, the orthogonal views "navigation" screen was just showing blue. All other buttons appeared normal and they were able to use the mouse and toggle through screens and different layouts, all were just showing a blank blue screen. The surgeon did not want to reboot and opted to bring a new system into the room to continue the procedure. The procedure was delayed by less than one hour and there was no impact on patient outcome.
 
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Brand NameSTEALTHSTATION S7 NAVIGATION
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10729269
MDR Text Key212836384
Report Number1723170-2020-02786
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
Report Date 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
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 Received10/16/2020
Was Device Evaluated by Manufacturer? Yes
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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