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	Death (1802); Iatrogenic Source (2498)
Date of Event	02/25/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier and weight not available from the journal article author upon request as the patient event was not related to any medtronic device.The identifier used as the article notes this patient as case 6.Date of death was not provided upon request from the author as the patient death was not related to any medtronic device.Journal article accepted date used: 2/25/2017.Event date is approximated.Date provided used is when the journal article was accepted.Citation: nagae, lm, honce, jm, nyberg, e, ojemann, s, et al.Imaging of laser therapy in epilepsy.J neuroimaging 2017;27:292-299.Doi: 10.1111/jon.12438.Per the journal article: the patient¿s death 10 months after the laser ablation was considered to be due to a seizure in her sleep¿though, a coroner¿s report was not available.In the context of having been seizure free and without an observed clinical event, it would fit sudden unexpected- death-in-epilepsy.Her vns was turned off before she underwent invasive monitoring and¿as a precaution¿her medications were never changed postoperatively.She had not reported any auras and no seizures were witnessed after her laser procedure.However, she was single and there could have been many occasions in which she was unobserved.Nevertheless, she was doing cognitively well, had enrolled in a nursing refresher class, and was driving again.Death is a known inherent risk of the procedure.Upon further follow up with the journal article author, it was reported that there has not been any new information from the coroner in regards to the cause of the patients death.She also reported that the patient death was unrelated to any medtronic device malfunction.Additional patient demographics were not provided as the patient death was not related to any medtronic device.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer for evaluation.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic thermal therapy system.There is no allegation to suggest that medtronic device caused or contributed to the reported event.
Event or Problem Description
The attached journal article was forwarded by a medtronic representative and reports the use of the thermal therapy system.This is report one of two.See 1723170-2017-03303.Per the article, mr-guided laser interstitial thermal therapy (mrglitt) is an increasingly popular neuroablative method for the surgical treatment of epilepsy patients.All patients presented with refractory epilepsy and, despite their different etiologies and variable location of the epileptogenic zones (ezs), all of them demonstrated some benefit from this neuroablative procedure, as described.(see table 1 for demographics, outcome, and follow-up.) a (b)(6)-year-old female with seizures since 17 years of age, with a right occipital open lip schizencephaly and multiple periventricular heterotopic nodules (figs 7a, b).Prior phase ii evaluation was performed years earlier; however, open resection was not pursued due to the risk of visual loss.Persistent seizures and progressive memory loss despite anti-epileptic drug (aed) and vagal nerve stimulator (vns) interfered with work and education and prompted the patient to seek laser ablation.Procedural sequela were limited to a left superior quadrant visual defect.Patient was seizure free, resumed school, and had the vns removed, as it was turned off as a precaution before invasive monitoring and never reactivated.Her medications were never changed postoperatively.Unfortunately, the patient was found dead 10 months after the procedure, the cause of death remaining unknown.Risk factors for recurrent seizures in her case were independent interictal epileptiform discharges recorded from both hippocampal formations and the fact that not all of the sizable cortical dysplasia was ablated.Laser ablation damaged parts of the posterior right heteroptopia, but remnants of it, and left and right hippocampus remained.This implies that she had bilateral hippocampal hyperexcitability and portions of the cortical dysplasia still in place to promote or generate another seizure.Subsequent discussions about how her death could have been prevented centered around trying to take as much lesional tissue as possible and to be vigilant about any seizure symptoms or signs.However, in her case, the resection was balanced against keeping as much of her visual cortex and optic radiation intact as possible to minimize a visual field defect¿ her expressed wish.Unfortunately, without experienced or observed clinical seizures, medications would not have been preemptively increased.Possibly, in the future, long-term monitoring for seizures¿and treatment¿with a responsive neurostimulation device could alert physicians earlier and provide treatment, if no further resection is possible or desired.Assessment of eloquent brain regions must be performed in all presurgical cases including prior to mrglitt, to evaluate the risk of post-procedure deficits (eg, visual field defects) (fig 7d).Coregistration software enabling the superimposition of functional mri (fmri) and tractography to the ablation system may be useful to assist with function preservation.Edema onset was seen 1¿3 days after the procedure, peaking after 4¿27 days (mean 6 days), and lasting for 15¿45 days (mean 23 days) in this study.The patient is monitored overnight in the hospital, not necessarily in the intensive care unit (icu), and placed on steroids for 1¿2 weeks, aiming to reduce inflammatory process and subsequent edema.Radiologic pathologic correlation previously made in cases of tumor laser ablation demonstrated that at 24 hours after the procedure, five distinct histologic concentric zones can be identified.The outermost layer is the marginal zone (zone 5), where the reversible postsurgical perifocal edema takes place (inherent risk of procedure).In conclusion, compared with open surgery, mrglitt is a relatively safe procedure, with decreased hospital stay, cost, pain, and decreased patient discomfort and quicker recovery.Mrglitt may allow better neuropsychological outcomes in some cases and maybe used as a definitive or palliative treatment procedure.Procedural complications do occur and include hemorrhage, infection, neurological deficits (transient or permanent), and death.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic 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: 6790010
• Report Number: 1723170-2017-03302
• Device Sequence Number: 130041
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: 07/17/2017
• Initial Report FDA Received Date: 08/11/2017
• 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: Death
• Patient Age: 36 YR