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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problems Human-Device Interface Problem (2949); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9735825, serial/lot #: unknown. Medtronic representative went to the site to test the equipment. Testing revealed that there was an axiem break out box communication failure. The axiem box was replaced. The system passed the system checkout and was found to be fully functional. Evaluation codes that apply to this analysis: 10, 114, 4307. The em intfce 9735825 s8 em instr intfce was returned to the manufacturer but was under analysis at the time of filing. Evaluation codes that apply: 4118, 3233, 11. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial biopsy procedure. It was reported that the instrument interface and emitter were not working. The site reseated both cables with no change. When opening emitter details the instrument interface showed that it was still initializing after more than 5 minutes of being plugged into the system. The site got another interface from a different system and the instrument interface and emitter began working immediately. There was a less than one hour surgical delay and no impact on patient outcome.
 
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Brand NameSTEALTHSTATION S8 PREMIUM SYSTEM
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 Key9451265
MDR Text Key183118018
Report Number1723170-2019-05955
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
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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