MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE LUA NSCLC

Model Number	TFT9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 60-year-old male patient with non-small cell lung cancer (nsclc) - adenocarcinoma started optune lua therapy on (b)(6) 2026.On (b)(6) 2026, a medical record was received by novocure documenting that, during an oncology follow up appointment on (b)(6) 2026, the patient had difficulty tolerating optune lua therapy, particularly overnight.The patient reported significant pruritus, heat, sweating, and severe discomfort while sleeping with the transducer arrays in place.The patient was able to tolerate device use better during daytime hours.The patient also reported sensations of experiencing claustrophobia, panic, hyperventilation, and intermittent shortness of breath when wearing the device.The spouse observed that the patient's anxiety increased due to concerns that the inability to wear the device could adversely affect his prognosis.The physician prescribed lorazepam to manage the patient's anxiety related to nighttime device intolerance.Several attempts were made to contact the prescribing physician with no reply.
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of device use to the patient´s anxiety, requiring medical intervention, cannot be ruled out.Anxiety has been reported in the pivotal ef-24 clinical trial for optune lua treatment for nsclc (4% overall in the ttfields arms and 2% overall in the control arms).Claustrophobic sensation, panic, hyperventilation, and intermittent shortness of breath were secondary symptoms of patient´s anxiety.Pruritus, heat sensation, hyperhidrosis, and discomfort were related to device use, although assessed as non-serious.

• Brand Name: OPTUNE LUA NSCLC
• Common Device Name: OPTUNE LUA
• Manufacturer (Section D): NOVOCURE GMBH; 21 neuhofstrasse; baar 6340 ; CH 6340
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; 2077527602
• MDR Report Key: 25123251
• Report Number: 3010457505-2026-00728
• Device Sequence Number: 20997952
• Product Code: SDA
• UDI-Device Identifier: 07290107983235
• UDI-Public: (01)07290107983235(11)250224
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P230042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: Lay User/Patient
• Device Model Number: TFT9200
• Device Catalogue Number: TFT9200US
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2021
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male