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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problems Mechanical Problem (1384); Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Date 03/28/2019
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 used outside of a procedure. It was reported that the site had just upgraded their software the week prior to the event. Since the update, when the site tests their connection with electronic picture archiving and communication systems (pacs) via a blank query, the system becomes unresponsive. They were able to use this method prior to the new software installation. The site also saw a low memory error at one point. When a filter is added, then they are able to query. It was recommended to the have the site check with their electronic picture archiving and communication systems (pacs) to determine if they have "only query" enabled now that the port handles both functions. There was no patient involvement in this event.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through known anomaly determination. 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.
 
Manufacturer Narrative
Additional information: additional information and initial reporter provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional information that the system was working without issue. For the first week, the site had to apply a filter to get the system to work but now they were waiting a little longer before attempting and the system was working without issue.
 
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Brand NameSURGN CART 9735665 STEALTH S8 PREMIUM
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 Key8495676
MDR Text Key141342850
Report Number1723170-2019-01620
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
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,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2018
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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