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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 Environmental Compatibility Problem (2929)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding a navigation system. It was reported that during a case, the system powered down three times. They were able to registered the patient and continue with the surgery after rebooting the system after each shutdown. There was no impact to the patient impact and delay was less than an hour.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative replaced the umbilical cord between camera cart and main cart and replaced the ups on main cart. The system was holding charge as expected. Continuation of concomitant medical products: other relevant device(s) are: product id: 9735772, ( cable extrnl main to cam s8 svc) and product id: 9735788,( ups camera cart s8 svc). 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 Key13020469
MDR Text Key289666370
Report Number1723170-2021-02907
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
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
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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