MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Speech Disorder (4415)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that aphasia is related to tumor progression and unrelated to optune therapy.Aphasia was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (11% and 8% in optune/tmz and tmz arms respectively) and is a known complication of the underlying disease (gbm).
Event or Problem Description
A 52 year old male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2022.On (b)(6) 2023, novocure was informed that the patient was scheduled for an unspecified surgery on (b)(6) 2023.Optune therapy was temporarily discontinued.On (b)(6) 2023, the prescribing physician reported the patient experienced worsening expressive aphasia and on an unspecified date, underwent a craniotomy and resection.On (b)(6) 2022, brain mri and rcbv (relative cerebral blood volume), demonstrated enhancement along the surgical cavity compared to prior mri on (b)(6) 2022.Suspected combination of treatment effect from radiation and potential tumor progression.The physician assessed the cause of the event to be a combination of factors including underlying disease, disease/tumor progression, and optune therapy.

• Brand Name: OPTUNE
• Common Device Name: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 16284973
• Report Number: 3010457505-2023-00223
• Device Sequence Number: 20088475
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/02/2023

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
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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: ATORVASTATIN; BEVACIZUMAB; LEVETIRACETAM; ONDANSETRON; PANTOPRAZOLE; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 97 KG