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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SEE H10)

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SEE H10) Back to Search Results
Model Number S7
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
No procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states.The medtronic representative attempted additional reboots and resolved the issue.The navigation system was success used for a procedure later that day.A medtronic representative, following up with the site, opted to replace the computer.No parts have been received by manufacturer for analysis.
 
Event Description
A medtronic representative reported that the navigation system became unresponsive.To troubleshoot the issue the system was rebooted after which the system displayed "no input detected." the surgeon opted to complete the procedure without the use of the navigation system.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
 
Manufacturer Narrative
Correction unique device identifier (udi) now provided.
 
Manufacturer Narrative
The suspect computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
 
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Brand Name
CART 9734056 S7 STAFF SHRT 100-120V INTL
Type of Device
SEE H10)
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
7208902338
MDR Report Key6196747
MDR Text Key63375537
Report Number1723170-2016-05882
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 05/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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