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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 9733858
Device Problems Environmental Compatibility Problem (2929); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Other relevant device(s) are: product id: 9735225r, serial/lot #: (b)(4). Report source foreign country: (b)(6). The manufacturer representative went to the site to test the navigation system. The reported issue was confirmed and parts were replaced. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the computer does not switch on from time to time. No patient was present at the time of the event. Additional information was received stating that the issue occurred only once and that the computer was slow and the images freeze.
 
Manufacturer Narrative
The computer was returned to the manufacture for evaluation. After functional testing and visual/physical examination the reported issue was confirmed. The computer boots normally to the application screen. The computer booted normally multiple times during burn-in testing. The installed programs start and run normally. They found 4 bad sectors and 4 un-correctable sectors. A bad computer was observed. If information is provided in the future, a supplemental report will be issued.
 
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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 Key9445565
MDR Text Key183521624
Report Number1723170-2019-05936
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
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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