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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735665
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4), udi#: (b)(4). Software analysis determined that the reported behavior was consistent with a known software anomaly. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for an spinal procedure. After completing an image acquisition, the scan did not automatically transfer to the navigation system. When attempting to manually push the scan over to the navigation system, the site was unable to register with it. The site had to do a manual registration. Technical services advised to see if the scan had a nav tag. If there was no nav tag, the site would need to retake the image acquisition or do manual registration. It was determined that the image did not have a nav tag. The site decided to retake the image acquisition. The issue was considered resolved. The reported issue resulted in a procedure delay of less than one hour. The impact to the patient was not provided.
 
Event Description
Medtronic received information regarding a navigation system being used for an spinal procedure. After completing an image acquisition, the scan did not automatically transfer to the navigation system. When attempting to manually push the scan over to the navigation system, the site was unable to register with it. The site had to do a manual registration. Technical services advised to see if the scan had a nav tag. If there was no nav tag, the site would need to retake the image acquisition or do manual registration. It was determined that the image did not have a nav tag. The site decided to retake the image acquisition. The issue was considered resolved. The reported issue resulted in a procedure delay of less than one hour. The impact to the patient was not provided.
 
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4), udi#: (b)(4). Software analysis determined that the reported behavior was consistent with a known software anomaly. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION¿ S8 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13004070
MDR Text Key285825859
Report Number1723170-2021-02887
Device Sequence Number1
Product Code HAW
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 Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2021
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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