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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 Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2018
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. Device manufacturing date is unavailable. The 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 pulling out and reconnecting the memory in the computer resolved the issue. A computer was replaced. The system then passed the system checkout and was found to be fully functional. The computer was returned to the manufacturer for analysis. Analysis found that during initial power on the system booted to home screen successfully. No issues during software launch and load/build multiple 3d models. No errors were found on hard drive. Computer passed all tests. No fault found.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure. It was reported that after inserting a tube, while giving anesthetic to the patient, image data was being input to the system. The patient's head was not fixed yet. At that time, "no signal" was indicated on the screen. The system was rebooted multiple times, but the issue persisted. Surgery was aborted and the surgery was postponed to a later date.
 
Manufacturer Narrative
Additional information: device manufacturing date 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
heather davis
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7691180
MDR Text Key114082002
Report Number1723170-2018-03466
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
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
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 Manufacturer07/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/16/2018 Patient Sequence Number: 1
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