MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 002-1100 15W THERMAL THERAPY; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	002-1100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Seizures (2063); Visual Impairment (2138); Iatrogenic Source (2498); Ptosis (2620)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation into the reported issue has been performed as there has been no allegation of deficiency against a medtronic product.Based on clinical knowledge of procedure type and per the clinical investigator, this is an inherent risk of the procedure.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's thermal therapy system.There is no allegation to suggest that medtronic device caused or contributed to the reported event.
Event or Problem Description
A medtronic representative reported on behalf of the site, that a patient underwent a laser induced thermal therapy (litt) procedure on (b)(6) 2017 for epilepsy.There were no reported delays to the procedure or issues with the thermal therapy system.There was a reported magnetic resonance imaging (mri) technical difficulty where software wasn¿t loading properly on the mri machine, and the computer had to be rebooted.Following the procedure, at 10:10 am, the patient was diagnosed with third nerve palsy of the left eye.The patient was reported to have diplopia and ptosis due to the third nerve palsy.The adverse event (ae) is reported to be secondary to receiving the thermal ablation procedure, but not related/due to the thermal therapy system itself.On (b)(6) 2017, the patient received an ophthalmology examination.The exam findings were reported as abnormal and clinically consistent with a left third nerve palsy - left eye limited motility and limited left eye.The patient returned on (b)(6) 2017 for evaluation, and per the neurological exam, it was confirmed that the patient has a partial cniii palsy of the left eye.No actions have been taken to treat this ae.No further actions are planned and the ae is unresolved.The reported event is associated with a clinical trial ((b)(4)) conducted under an investigational device exemption (ide).Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's thermal therapy system.There is no allegation to suggest that medtronic device caused or contributed to the reported event.

• Brand Name: SYSTEM 002-1100 15W THERMAL THERAPY
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6832891
• Report Number: 1723170-2017-03558
• Device Sequence Number: 13833681
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 002-1100
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 47 YR
• Patient Weight: 76