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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 No Display/Image (1183); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated. The system then passed the system checkout and was found to be fully functional.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure. It was reported that the pentero microscope was used and while navigation was available, the menu panel of the model outline indication was not displayed. During initial troubleshooting, after the procedure completed but while the micro and the navigation device were working, inspection was performed. A communication cable was found to be unplugged and was re-plugged. The menu panel of the model from indication displayed but a bracket was not recognized. The microscope was rebooted without resolution. After calibration software was started, it was noted that the bracket was recognized in the display calibration panel. The device was rebooted again and no more issues occurred. The procedure was completed with the use of navigation. There was no delay to surgery and no known impact on patient outcome.
 
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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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7659168
MDR Text Key113283445
Report Number1723170-2018-03114
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 foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
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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