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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 Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier field not sufficient to hold all digits, should read: (b)(6). Onsite functional and visual examination was performed by a manufacturer representative. A new ct scan was burning on a different disc and the issue was resolved. The system passed a system checkout and was returned to an operational condition. Analysis of the exam was performed and the issue was able to be replicated. Exam was able to load correctly on newer navigation system.
 
Event Description
Medtronic received information regarding a navigation device being used for a catheter placement procedure. It was reported that the system only loaded 90/200 slices, resulting in an incomplete model. Burning a new disc resolved the reported issue. Manufacturer representative was able to duplicate the issue with the problematic disc at a later time. The surgeon opted to complete the procedure without navigation. There was no impact to patient. There was a reported delay to procedure of 45 minutes due to this 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
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7827590
MDR Text Key118593518
Report Number1723170-2018-04311
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 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2013
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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