MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Suicidal Ideation (4429)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that the patient experienced psychological stress due to optune gio therapy, therefore the contribution of the device to the suicidal ideation cannot be ruled out.Suicidal ideation was not reported as an expected event with optune gio device use in the (ef-11 or ef-14 trial in optune arm).Suicidal ideation is well known in terminally ill patients.One study found that 45% of terminal cancer patients had suicidal non-persistent thoughts while 9% had suicidal ideation (madeira et al., j psychosoc onc, 2011, 29:636-642).There have been 27 reports of suicidal ideation in the commercial program to date.
Event or Problem Description
A 72-year old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.In a medical record received on (b)(6) 2024, it was noted that on (b)(6) 2024, the patient ended optune gio therapy.Optune gio therapy was discontinued due to disruption of daily activities due to the product giving high-temperature alarms while hiking and at night, keeping her and her partner awake.Patient reported her quality of life had diminished since starting optune gio therapy.Reportedly, patient canceled a planned trip as patient experienced passive suicidal ideation associated with optune gio therapy.On (b)(6) 2024, the prescribing physician informed novocure that the patient did not require hospitalization or treatment for the event, and was not experiencing disease progression at the time.According to the prescriber, the patient had made a passive suicidal ideation comment to her significant other at home.Per the prescriber, the patient's frustration with the device and its limitations (i.E., she couldn't hike with it on without the electrodes overheating and causing the machine to alarm, frequent wakeups at night due to noise made by the device), caused the event.
Additional Manufacturer Narrative
Clarification to section h.10 of the initial report: in the optune gio commercial program, the observed frequency of suicidal ideation, regardless of relatedness to device, is 0.08%, with 27 reports of suicidal ideation to date.This is the only case out of the 27 reported events that was assessed as related to device use by a healthcare provider (hcp) or by novocure.Correction to section a.2.Of the initial report: date of birth is february 23, 1952.Follow-up information: review of device logfile data showed multiple device alarms, most commonly "therapy timeout" errors caused by the patient not turning on therapy after turning on the device.Novocure was informed on july 15, 2024, that the patient had entered hospice.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 19688105
• Report Number: 3010457505-2024-00290
• Device Sequence Number: 7093732
• Product Code: NZK
• UDI-Device Identifier: 07290107982214
• UDI-Public: (01)07290107982214(11)201227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• 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): 07/26/2024

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: TFH9100
• Device Catalogue Number: TFH9100US
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2020
• 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: CALCIUM ASCORBATE; COLLAGEN; GABAPENTIN; LEVETIRACETAM; MULTIVITAMIN; ONDANSETRON; VITAMIN B6; VITAMIN D3; ZINC ACETATE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 107 KG