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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S8 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735669
Device Problem Imprecision (1307)
Patient Problems Tissue Damage (2104); Brain Injury (2219)
Event Date 12/28/2018
Event Type  Injury  
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess). It was reported that when the health care professional (hcp) entered the brain using the microscope, the hcp verified that they breached the dura. The hcp collaborated with neurology and is patching the breach with duragen and will have an lp shunt while being observed by neurology intensive care unit (icu). Navigation was aborted causing more than an hour delay in the procedure. Patient was affected. The manufacturer representative gave an update about the reported issue. The patient spent 3 days in neuro intensive care unit (icu) and then they were moved to a floor for further treatment with a pic line after white blood cells were found in the cerebrospinal fluid (csf) pulled from the lumbar drain. The health care professional was inaccurate to a quarter of an inch. Accuracy had been verified at the beginning of the case and throughout after it was noticed that the right side, second side where the injury occurred, was not as accurate as the left side had been. They checked the sphenoid and noted that while they were on the roof of the sphenoid the system showed them having a quarter inch to go to hit the roof.
 
Manufacturer Narrative
The software investigation was unable determine the probable cause of the reported issue. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess). It was reported that when the health care professional (hcp) entered the brain using the microscope, the hcp verified that they breached the dura. The hcp collaborated with neurology and is patching the breach with duragen and will have an lp shunt while being observed by neurology intensive care unit (icu). Navigation was aborted causing more than an hour delay in the procedure. Patient was affected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameS8
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8267743
MDR Text Key133754215
Report Number1723170-2019-00358
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169838918
UDI-Public00643169838918
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735669
Device Catalogue Number9735669
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2018
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: 01/22/2019 Patient Sequence Number: 1
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