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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problem Imprecision (1307)
Patient Problems Erythema (1840); Pain (1994); Visual Impairment (2138); Loss of Vision (2139); Unspecified Tissue Injury (4559)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
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, in the form of a lawsuit, regarding a navigation system being used during a functional endoscopic sinus surgery (fess) to treat chronic sinusitis with a deviated suptum, hypertrophic inferior nasal turbinates and middle turbinates. The lawsuit alleged that the patient's right eye socket (the lamina papyracea) had been breached with navigated instrumentation, and subsequently severed the medial rectus. The lawsuit alleges that the patient experienced pain, diplopia, difficulties with depth perception, nausea, blurred vision, redness, disorientation with movement, vision loss for extended periods of time, and limited ocular movements. The patient alleges a revision surgery was conducted following the alleged incident. The lawsuit alleges that the patient's right eye is permanently positioned 18 degrees to the right. An allegation that the navigation system malfunctioned was made in the lawsuit.
 
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Brand NameFUSION COMPACT
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11457136
MDR Text Key245601693
Report Number1723170-2021-00641
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
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

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
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