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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC S7 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2020
Event Type  malfunction  
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation. Concomitant medical products: other relevant device(s) are: product id: 9733686, version 2. 1. 0. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure. It was reported that during a case the surgeon felt inaccurate immediately after registration. The surgeon was using a mayfield and cranial reference frame. The surgeon felt off by 5mm deep. They attempted to resolved by re-spinning with the medtronic imaging system they were using for the case, but the new exam had the same issues. There was a reported delay of 10 minutes and no reported impact to patient outcome. Medtronic received information that the surgeon opted to complete the procedure compensating for the imprecision.
 
Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative. The representative was unable to replicate the reported event. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameS7 STEALTHSTATION NAVIGATION SYSTEM
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 Key9962075
MDR Text Key188403763
Report Number1723170-2020-01222
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,Followup,Followup,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2011
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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