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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 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations. A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined. Other relevant device(s) are: product id: 9733686, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that, while in a procedure, the navigation system was intermittently tracking instruments. It was reported that the tool cards were displayed to be disconnected while the camera was connected. It was noted that 17 tool cards had been selected to the procedure. There was no reported impact on patient outcome.
 
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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 Key9823437
MDR Text Key183295292
Report Number1723170-2020-00855
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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