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	Unspecified Infection (1930); Memory Loss/Impairment (1958); Seizures (2063); Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)
Date of Event	02/25/2017
Type of Reportable Event	Serious Injury
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 3.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: mrglitt is relatively safe, however, it is not devoid of complications.The main complications of the procedure include hemorrhage, infection, and neurological deficits.Two fatalities were reported in a 102 case series, due to refractory malignant edema.The main advantage of mrglitt over radiofrequency thermocoagulation is the possibility to monitor local and critical zone temperatures near real time, with a mechanism of disabling laser delivery at the established limits.Real tissue damage, however, is produced by ablation and, the risk of permanent neurological deficits should be considered.A prior case report described disabling amnestic syndrome after laser ablation of a hypothalamic hamartoma, resulting from injury to the mammillary bodies in a patient with prior right temporal lobectomy.Upon further follow up with the journal article author, it was reported that the patient events were unrelated to any medtronic device malfunction.Per the author, the infection was systemic (either urinary of upper respiratory), treated as outpatient, not related to a medtronic device.The incomplete ablation of the left hippocampus was due to the original placement of the catheter, not due to the thermal therapy system malfunction.Additional patient demographics were not provided as the patient events were not related to any medtronic device.Infection and neurological deficits are known inherent risks of the procedure.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 two of two.See 1723170-2017-03302.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 presented with refractory epilepsy and a left anterior mesial temporal focus was demonstrated at phase ii monitoring congruent with left mts (fig 4a).Due to a prominent choroid plexus just superior to the atrophic left hippocampus (fig 4b), the laser fiber was stereotactically placed slightly more inferior than normally desired to avoid hemorrhage.The ablation zone included the inferior aspects of the amygdala and the inferior portion of the hippocampus and parahippocampal gyrus (fig 4c).However, it was not possible to extend it to the superior portion of the hippocampus despite longer ablation times and varying the laser power.Residual hippocampus was seen on follow-up imaging (fig 4d).Case 3 patient has been followed for 19 months.She had one seizure after the procedure which may have been triggered by infection and two other episodes since then, which were brief (prior to surgery, frequency was 1¿2 seizures/week).Small remnant hippocampus was seen on follow-up mri (fig 4d), amenable for further ablation, if clinically warranted.The patient also experienced memory problems.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.Radiologicpathologic 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: 6790056
• Report Number: 1723170-2017-03303
• Device Sequence Number: 18864374
• 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,foreig
• 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: Other; Disability
• Patient Age: 69 YR