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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 Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
The software investigation found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database.
 
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations. No procode, common device name, unique device identification (udi) and/or 510k provided as this device is not released for distribution in the united states. No parts have been received by the manufacturer for evaluation. Part not returned for analysis.
 
Event Description
A medtronic representative reported that, while in a spinal fusion, the navigation system became unresponsive prior to use of the medtronic imaging system. It was noted that the navigation system exited without prompt from the user. To complete the procedure, a second medtronic navigation system was used. There was no reported delay to the procedure due to this issue. There was no impact on patient outcome. No additional information was provided.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSEE 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
MDR Report Key7126365
MDR Text Key103040315
Report Number1723170-2017-05150
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
Report Date 01/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2014
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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