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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/16/2017
Event Type  malfunction  
Manufacturer Narrative
The software investigation found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device lot number, or serial number, unavailable. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. A medtronic representative tested the system and was able to replicate the issue. No parts were replaced. No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of procedure, an unexpected exit of the application occurs when two identical transforms are fed to the flouro merge algorithm. It was reported that the same issue would occur when the same image acquisition is used for both anterior posterior (ap) and lateral images. When acquiring images whose transforms are nearly perpendicular this issue would not occur. There was no patient present at the time of the issue.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7119663
MDR Text Key103038862
Report Number1723170-2017-05128
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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