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

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.

Manufacturer Narrative

H3, h6: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11457136
• MDR Text Key: 245601693
• Report Number: 1723170-2021-00641
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• 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 Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention