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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Device Sensing Problem (2917)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 9735585, serial/lot #: 3. 1. 2. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a transsphenoidal procedure. It was reported that the crosshairs were moving even when the surgeon was holding the instrument still. This was reported post-case so no troubleshooting could be done. It was an electromagnetic (em) case and occurred with the malleable suction and the stylet. It was unknown if the issue occurred superficially as well. Tracking details were unavailable. According to the representative, the image did not look like it was zoomed in/magnified too much to catch small details. The surgeon had an endoscope in the case but it was not known where it was in relation to the instruments when the issue occurred. There was no delay to the procedure and no impact to the patient.
 
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Brand NameSTEALTHSTATION S7 NAVIGATION
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 Key10413441
MDR Text Key203139229
Report Number1723170-2020-02180
Device Sequence Number1
Product Code PGW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
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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