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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 SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. 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. A medtronic representative went to the site to test the equipment. Testing revealed that the computer of the navigation system was replaced to restore functionality. The system then passed the system checkout and was found to be fully functional. The computer has not been received by the manufacturer for evaluation. Device manufacture date is unavailable.
 
Event Description
Medtronic received information that, while outside of a procedure, the navigation system application software logged out without prompt from the user when selecting a surgeon profile. Restarting the navigation system did not restore functionality. For subsequent procedures, a second medtronic navigation system was used. There was no patient present when this issue was identified. No additional information was provided.
 
Manufacturer Narrative
The computer for the navigation system was returned to the manufacturer for evaluation. Testing found that the navigation system would become unresponsive when selecting the surgeon profile in the spinal application software. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Manufacturer Narrative
Manufacturer updated to proper value.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSIMILAR DEVICE: NEUROLOGICAL 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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7626642
MDR Text Key111983347
Report Number1723170-2018-02926
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 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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