MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH-9100

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

Patient Problem Seizures (2063)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the seizures were 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) year old male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019, as part of the ist, "a phase 1 trial of novottf-200a prior and concomitant to radiotherapy and temozolomide in newly diagnosed glioblastoma".On december 04, 2019, novocure was informed that the patient had experienced minor seizure activity on (b)(6) 2019.On (b)(6) 2019, patient was hospitalized after experiencing a generalized tonic-clonic seizure and fever (104 degrees) with possible meningitis.Optune therapy was temporarily discontinued.Patient did not have a history of seizures and was started on antiepileptic medication (levetiracetam 1000 mg).Lumbar puncture confirmed meningitis due to high protein, lactate, albumin and cerebral spinal fluid cells.Patient was started on antipyretic (metamizole, paracetamol), antibiotic (ampicillin, ceftriaxone) and antiviral (aciclovir) medications with improvement during the hospital stay.On (b)(6) 2019, patient was transferred to radiotherapy department for treatment.On (b)(6) 2019, patient experienced an additional seizure.On (b)(6) 2019, patient was discharged home in stable condition.Prescribing physician assessed meningitis as possibly related to the combination of radiotherapy and chemotherapy (temozolomide) and unrelated to optune therapy.Prescriber stated that after optune therapy was interrupted, patient did not experience any additional seizures and therefore assessed the seizures as possibly related to optune.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer (Section G): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 6033191907
• MDR Report Key: 9532101
• MDR Text Key: 189190772
• Report Number: 3009453079-2019-00132
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

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: TFH-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 32 MO
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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: 45 YR
• Patient Weight: 93