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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Operating System Becomes Nonfunctional (2996); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: cmptr 9735225r rollingstone s7 refurb. No devices have been evaluated at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used outside of a procedure. It was reported that the system was freezing up. The issue was able to be replicated during testing of the system and confirmed it occurs at various times including boot up and within the software. The video also got distorted. It was reported that the probable cause was due to the computer. There was no patient present at the time of the event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional information that the cause of the issue was unknown.
 
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Brand NameS7
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 Key9930718
MDR Text Key186751125
Report Number1723170-2020-01165
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2012
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/26/2012
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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