MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Thrombosis/Thrombus (4440)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to a remaster sae form, it was reported that a patient experienced hemianesthesia post-operatively following a litt procedure, which remained unresolved through the 3-month follow-up visit.The event is described as "dense left hemibody sensory deficit (distal foot and left face able to feel pain)".The patient was provided with occupational and physical therapy.
Additional Manufacturer Narrative
Sensory and motor deficits are documented perioperative risks for brain surgeries such as mri-guided neurosurgical ablation.This documentation is available in the neuroblate ifu and in monteris' internal risk management files.No malfunction was alleged, therefore, no device evaluation was performed.
Additional Manufacturer Narrative
Sensory/motor deficits and deep vein thrombosis are documented perioperative risks for brain surgeries such as mri-guided neurosurgical ablation.This documentation is available in the neuroblate ifu and in monteris' internal risk management files.No malfunction was alleged; therefore, no device evaluation was performed.This supplementary is being submitted to capture the additional information received from the event.
Event or Problem Description
According to a remaster sae form, it was reported that a patient experienced hemianesthesia post-operatively following a litt procedure, which remained unresolved through the 3-month follow-up visit.The event is described as "dense left hemibody sensory deficit (distal foot and left face able to feel pain)".The patient was provided with occupational and physical therapy.On 15-oct-2025, additional information from the remaster sae was retrieved during a remaster safety committee meeting.On post-study procedure day 40-47 ((b)(6) 2025 to (b)(6) 2025), patient presented to the emergency department with increased concerns regarding left lower extremity (lle) weakness.An acute lle deep vein thrombosis (dvt) was identified, and the patient underwent a thrombectomy before initiating anticoagulants.On post-study procedure day 57 ((b)(6) 2025), medical oncology noted that the patient was still experiencing numbness in left arm and leg.The patient noted having functional use of extremities but continues to use a wheelchair for additional support.On post-study procedure day 75 and 81 ((b)(6) 2025), patient re-started occupational and physical therapy to address the functional deficits from continued left hemibody anesthesia.On post-study procedure day 96 ((b)(6) 2025), the patient had improvement in left upper extremity (lue) but continued to note experiencing reduced strength, sensation, and control of fine motor skills.On post-study procedure day 130 ((b)(6) 2025), patient "continue[d] to display left sided gait deviations and impaired coordination that impact[ed] her mobility".On post-study procedure day 170 ((b)(6) 2025), occupational therapy noted patient continued to experience challenges with grasping items with their left hand.This information was reviewed by the remaster safety committee on (b)(6) 2025 and determined that the event was possibly related to the litt procedure and possibly related to the surgical procedure.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: michelle bergstrom ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 22040117
• Report Number: 3009970070-2025-00006
• Device Sequence Number: 9095703
• Product Code: GEX
• UDI-Device Identifier: 00816589021080
• UDI-Public: 00816589021080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K193375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Model Number: 20980
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Sex: Unknown