MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Seizures (2063)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizure was related to the underlying disease (gbm) and unrelated to optune therapy.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).

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019.On (b)(6) 2019, novocure was informed that the patient had been hospitalized on an unspecified date.On (b)(6) 2019, the prescribing physician reported that the patient had been hospitalized on (b)(6) 2019, after he presented with symptoms of new onset simple partial seizures, including aphasia, left-sided weakness, left-sided facial palsy and uncontrolled twitching in his jaw.Patient was taking prophylaxis anti-seizure medication (levetiracetam 500 mg daily) at the time of the event.Patient was treated by increasing levetiracetam to 1000 mg bid.There was no further seizure activity during the hospital stay, however, residual facial tremors and dysarthria continued and eventually resolved.Patient was subsequently found to have a small stroke and was started on aspirin and continued on simvastatin.Patient was also noted to have dysarthria, dysphagia, and chemotherapy-induced pancytopenia.On (b)(6) 2019, patient was discharged to a rehabilitation facility.On (b)(6) 2019, patient was readmitted after presenting with seizure like activity including facial twitching and dysarthria.Patient subsequently underwent a witnessed fall in the emergency room resulting in nondisplaced nasal bone fractures.Patient was found to be experiencing focal partial seizures, likely in the setting of glioblastoma and recent radiation.Brain mri revealed increased enhancement suggestive of edema versus recurrence.Eeg was abnormal.Treatment included additional anti-seizure medication (lacosamide).Patient was noted to be encephalopathic and was frequently asking to leave the hospital.The patient's healthcare proxy was invoked.Over the course of his stay, seizures resolved and mentation significantly improved.On (b)(6) 2019, patient was discharged to a skilled nursing facility.Discharge diagnoses included focal seizures, cerebral edema, and acute metabolic encephalopathy.Prescriber stated that the seizures were unlikely caused by gbm recurrence and that optune therapy could not be ruled out as a cause.

Manufacturer Narrative

On (b)(6), 2021, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4-suspect medical device model number.Corrected model number is tfh9100.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 9233071
• MDR Text Key: 170427066
• Report Number: 3009453079-2019-00125
• Device Sequence Number: 1
• Product Code: NZK
• 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,Followup
• Report Date: 01/07/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 41 MO
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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: ALLOPURINOL; COLCHICINE; DABIGATRAN ETEXILATE; LEVETIRACETAM; ONDANSETRON; PANTOPRAZOLE; SIMVASTATIN
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 108 KG