MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Fall (1848); Convulsion/Seizure (4406)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy.The fall was unrelated to optune.Seizures were reported as adverse events 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 (22% and 21% in optune/tmz and tmz arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of gbm and have been reported as the presentation symptom in 27% of cases.During the course of the disease, 51% of patients will experience seizures (clin neurol neurosurg.2015; 139:166-171).Risk factors for seizure in this patient include: concomitant temozolomide (convulsions are listed as among the most common adverse reactions.Source: temozolomide prescribing information) and concomitant dexamethasone (convulsion is listed as a known adverse reaction.Source: dexamethasone prescribing information).Fall is an expected event with device use and 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 (8% and 3% in optune/tmz and tmz arms respectively).

Event Description

A (b)(6) male with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2021.On (b)(6) 2021, caregiver reported to novocure that the patient had been discharged from the hospital following a fall and seizures.The prescriber reported the fall was not associated with the seizure and the patient was not hospitalized.The patient had a known seizure history and per medical records prophylactically on levetiracetam 1000 mg twice daily and lacosamide 50 mg twice daily.Per prescriber, the fall was unrelated to the seizure activity.Prescriber assessed the underlying cause of events to be associated with glioblastoma, seizure disorder, optune therapy, chemotherapy, and prior radiation.

Manufacturer Narrative

On (b)(6), 2021, novocure discovered the optune device serial number and manufacture date was incorrectly entered in sections d4 and h4.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• MDR Report Key: 12457100
• MDR Text Key: 272135811
• Report Number: 3009453079-2021-00181
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

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: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/11/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACLOFEN; BEVACIZUMAB; DEXAMETHASONE; LACOSAMIDE; LEVETIRACETAM; LOSARTAN; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR