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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 Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier not available from the site. Patient weight not available from the site. The software investigation found that the reported event was unrelated to a software issue as the reference frame was reported to have moved during the procedure. The software functioned as designed.
 
Event Description
A site representative reported that, while in a scoliosis spinal fusion, a second image acquisition was reported to be inaccurate. The imprecision was noted after moving the patient frame to the next position for the procedure and performing the image acquisition. After the second image acquisition, the instruments were re-verified and the procedure was completed. It was reported that there was suspected movement of the reference frame, resulting in the imprecision. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no known impact on patient outcome. No additional information was provided.
 
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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
MDR Report Key7133712
MDR Text Key95480303
Report Number1723170-2017-05225
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169505742
UDI-Public00643169505742
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2016
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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