MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the cerebral hemorrhage was unrelated to optune therapy.Cerebral hemorrhage is a known complication of the underlying disease.Cerebral hemorrhage 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 (1% and 2% in optune/tmz and tmz arms respectively).

Event Description

A 39-year-old male with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2023.Novocure was informed by patient´s spouse on (b)(6) 2023 that the patient had been experiencing headaches for several days and went to the emergency clinic that day.The patient was diagnosed with cerebral hemorrhage and was hospitalized the same day.Optune therapy was temporarily discontinued as of (b)(6) 2023.The patient underwent lumbar puncture and was diagnosed on (b)(6) 2023, with meningeal dissemination.On (b)(6) 2023, an mri scan was performed confirming the diagnosis.The patient did not recover, nonetheless, he was discharged home on (b)(6) 2023, with unspecified medical treatment.The prescriber was contacted for causality assessment.According to the prescriber, the possibility of a causal relationship between the event and optune therapy seems very low.However, he could not completely deny a causal relationship to optune.The prescriber mentioned that the hemorrhage occurred contralateral to the tumor and did not seem to be attributed to age related hypertension, considering the patient´s relatively young age at the time of the event.The prescriber reported that they have not been able to identify a clear cause for the event.

• 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: 17297875
• MDR Text Key: 319048384
• Report Number: 3010457505-2023-00241
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• 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: TFH9100JP
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male