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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated. The system then passed the system checkout and was found to be fully functional. Concomitant medical products: product id: 29631, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system and an automated trajectory guidance unit being used in a catheter placement procedure. It was reported that the targeting unit (tu) could not be aligned to the target. It was reported that the alignment circle could not be centered and allow the unit to enter "monitor mode". It was reported that the facility re-aligned, changed the ratcheting arm position, the approach of the sa, replaced the guiding joints and metal guiding pieces. It was suspected that something related to the operating room (or) table not being fixed enough caused the reported issue. There was a reported delay to the procedure of more than 1 hour due to this issue. There was no reported impact on the outcome of the patient.
 
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Brand NameSTEALTHSTATION S8 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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key11005493
MDR Text Key221842570
Report Number1723170-2020-03272
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2018
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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