MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE LUA

Model Number	TFT9200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyskinesia (2363)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that this event is unrelated to optune lua therapy and is related to underlying disease (nsclc).As the physician was unable to rule out a possible contribution of optune lua therapy to the event, novocure is reporting out of an abundance of caution.Dyskinesia was not reported in the pivotal ef-24 clinical trial for optune lua treatment for nsclc.Dyskinesia has not been reported in the optune lua commercial program to date.
Event or Problem Description
A 79-year-old male with non-small cell lung cancer (nsclc) began optune lua therapy on (b)(6) 2026.On (b)(6) 2026, the patient's spouse informed novocure that the patient experienced weakness on the left side including the arm, hand, and leg immediately following the removal of the transducer arrays from the torso.On (b)(6) 2026, the spouse described the patient's symptoms as it appeared that he had no control of his movements, which lasted approximately 30 minutes.The patient was transported to the emergency room (er) where he was monitored overnight.During the hospitalization, the patient underwent diagnostic testing including a magnetic resonance imaging (mri) scan, which showed no evidence of a cerebrovascular accident or other acute findings.The er physician indicated that the event may have been related to device use.On (b)(6) 2026, the prescribing physician reported that the patient was hospitalized due to involuntary arm movements and temporarily discontinued optune lua therapy.At that time, the patient did not experience disease progression.The physician assessed that the event was likely caused by optune lua therapy.
Additional Manufacturer Narrative
In the initial report pma number in section g4.Is incorrect.The correct pma number is (b)(6).

• Brand Name: OPTUNE LUA
• Common Device Name: OPTUNE LUA
• Manufacturer (Section D): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer (Section G): NOVOCURE GMBH; neuhofstrasse 21; baar, 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover st.; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 24636750
• Report Number: 3010457505-2026-00706
• Device Sequence Number: 8953504
• Product Code: SDA
• UDI-Device Identifier: 07290107983129
• UDI-Public: (01)07290107983129(11)201129
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; CALCIUM.; CEPHALEXIN.; DENOSUMAB.; EYE VITAMIN.; GABAPENTIN.; MULTIVITAMIN.; PREDNISONE.; SIMVASTATIN.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male