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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER NON-INVASIVE EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC PATIENT TRACKER NON-INVASIVE EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734887
Device Problem Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2020
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 instrument that was used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the stingray was not tracking and caused delay to the case. It was later discovered that the site had a bad tracker which was then swapped for a new one and case continued. There was a reported delay of less than one hour. There is no known impact on patient outcome.
 
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Brand NamePATIENT TRACKER NON-INVASIVE
Type of DeviceEAR, NOSE AND THROAT 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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10508768
MDR Text Key206161781
Report Number1723170-2020-02397
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734887
Device Catalogue Number9734887
Device Lot NumberUNKNOWN
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 Received08/19/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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