MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Speech Disorder (4415)

Event Date 01/12/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 308654430
• Report Number: 3010457505-2023-00223
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; BEVACIZUMAB; LEVETIRACETAM; ONDANSETRON; PANTOPRAZOLE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 97 KG