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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 Imprecision (1307)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that whilst performing a biopsy case a rep expressed not remembering whether he had made a new point of entry before navigating the needle with the surgeon. While they were actively sampling, the rep was advised to put the vertec probe back in the entry point to confirm their accuracy to their plan. When they put the vertec probe in the aiming device, it was reporting 10mm from target. The surgical team were then having trouble getting the plan to realign to the original target and had to made a new plan on the spot. Superficial bleeding was reported. There was less than an hour of delay.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that whilst performing a biopsy case a rep expressed not remembering whether he had made a new point of entry before navigating the needle with the surgeon. While they were actively sampling, the rep was advised to put the vertec probe back in the entry point to confirm their accuracy to their plan. When they put the vertec probe in the aiming device, it was reporting 10mm from target. The surgical team were then having trouble getting the plan to realign to the original target and had to made a new plan on the spot. Superficial bleeding was reported. There was less than an hour of delay.
 
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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 Key12984206
MDR Text Key285493413
Report Number1723170-2021-02873
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,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
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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