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	Headache (1880)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that a contribution of device use to the headache cannot be ruled out.Nausea is a common secondary symptom of headache.Headache is an expected event with optune gio device use (ef-11 16% and 28% ef-14 optune arm).
Event or Problem Description
A 49-year-old female with recurrent glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.Novocure was informed on (b)(6) 2024, that the patient experienced headaches and nausea since starting optune gio therapy.On (b)(6) 2024, the patient's caregiver reported that the patient was hospitalized and temporarily discontinued optune gio therapy since (b)(6) 2024.Novocure received additional information on (b)(6) 2024, that the four days the patient was on optune gio therapy, she was miserable due to headaches that subsequently led to being hospitalized.Per an available medical record, it was discovered the patient had a history of chronic migraine headaches without aura.The patient ended optune gio therapy on (b)(6) 2024.The prescribing physician was contacted for further details without reply.

• 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: 19630982
• Report Number: 3010457505-2024-00292
• Device Sequence Number: 8793721
• Product Code: NZK
• UDI-Device Identifier: 07290107982214
• UDI-Public: (01)07290107982214(11)160818
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2016
• 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: ALBUTEROL; DEXAMETHASONE; FUROSEMIDE; GABAPENTIN; LORAZEPAM; MECLIZINE; ONDANSETRON; PANTOPRAZOLE; SPIRONOLACTONE; TORSEMIDE
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 115 KG