MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Headache (1880); Myalgia (2238)

Event Date 01/13/2022

Event Type  Injury  

Event Description

A (b)(6) year old male patient with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2021.On (b)(6) 2022, novocure was informed by the prescribing site nurse that on (b)(6) 2022, the patient's primary care physician (pcp) reported the patient experienced severe headaches with body aches and contemplated hospital admission.Optune therapy was temporarily discontinued.On the same day, the patient presented to the emergency department with approximately one week history of headaches, general malaise, and myalgia.Headache did not seem positional or worse with movement or associated with any neck pain.Head ct demonstrated no evidence of acute intracranial pathology.Ed physician suggested lumbar puncture due to elevated white blood count (17,000) to rule out meningitis however, the patient declined given the risks.After administration of intravenous fluids and pain medication (ketorolac) he had relief.Per prescribing physician, patient was hospitalized due to severe headaches and body pains and received no treatment.Patient was likely experiencing disease progression and the cause of the event likely a side effect from optune therapy.Optune therapy was discontinued.

Manufacturer Narrative

Novocure medical opinion is that while a contribution of device use to the headache cannot be ruled out the event is likely due to underlying disease and gbm progression.Myalgia is unrelated to optune therapy.Headache was reported on the pivotal ef-11 recurrent gbm trial as an adverse event in both arms of the trial (16% optune therapy and 10% chemotherapy arm).They were attributable to the device in 3% of cases and to chemotherapy in 2% of cases.Headache is also a common symptom of disease in gbm.Myalgia is not an expected event with device use in the pivotal (b)(6) recurrent gbm trial.There have been 9 reports of myalgia in the commercial program to date.

• 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: 13506315
• MDR Text Key: 285750660
• Report Number: 3010457505-2022-00201
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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
• Treatment: BEVACIZUMAB; COMPAZINE; HUMULIN; LEVETIRACETAM; LISINOPRIL; LORAZEPAM; METFORMIN; ONDANSETRON; PANTOPRAZOLE; SIMVASTATIN; TEMOZOLOMIDE; TRAZODONE
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 125 KG