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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 Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 29631, serial/lot #: (b)(4); product id: 25650, lot/serial #: unknown. 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 an automated trajectory guidance unit being used in an electrode and probe placement procedure. It was reported that there was system movement when locked. It was stated that when placing the 2nd fiber for the thermal therapy case, when the drill was placed in the targeting unit (tu) the alignment error was drifting between 0. 2mm-1. 5mm. The health care professional had to hold the tu and counter the weight of the drill in order to get the alignment error to be accurate. They were able to place the fiber accurately. There was a 5 minute delay to the case. No impact on patient outcome.
 
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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 Key13366846
MDR Text Key288780465
Report Number1723170-2022-00114
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
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Device Lot NumberN29806538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/22/2019
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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