MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/09/2021

Event Type  Injury  

Event Description

A (b)(6) year old male patient with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2021, as part of the investigator sponsored trial "optimalttf-2: enhancing tumor treating fields with skull remodeling surgery for first recurrence glioblastoma: a phase 2, multi-center, randomized, prospective, interventional trial".On (b)(6) 2021, novocure received a serious adverse event report.On (b)(6) 2021, at midnight, the patient experienced sudden worsening headaches that gradually increased to a six on the pain scale.The patient was unable to sleep as the headaches became worse when lying down.He took paracetamol, which did not help to alleviate the pain.On (b)(6) 2021, at 3:19am in the morning, the patient was hospitalized.There were no findings during neurological examination.Swelling was observed under the surgical incision (last surgical resection (b)(6) 2021).A ct-c was evident for hygroma located in the right frontoparietal area with midline shift and subcutaneous collection of cerebrospinal fluid (csf).Lab results were crp 58.2, leukocytes 10.1 and hemoglobin 7.2.The patient was treated with tramadol.On (b)(6) 2021, at 11:00am the patient was discharged to a neurosurgical outpatient clinic with recommendations to continue tramadol, observation and follow-up.During a follow-up appointment on (b)(6) 2021, the patient presented in improved condition.The patient's physician suspected the surgical resection to be the primary cause of the events.However, it could not be excluded by the physician that the skull remodeling surgery in combination with optune might have contributed.On november 30, 2021, novocure received an additional sae report.On (b)(6) 2021, the patient had been hospitalized due to focal seizures of the arm and face.The seizures were self-limited and the patient was awake during the seizures, followed by unspecified postictal symptoms.A mr-c showed tumor progression and subcutaneous csf.The patient was treated with increasing his levetiracetam dose to 750 mg two times daily.On (b)(6) 2021, the patient was discharged in habitual state.On (b)(6) 2021, the patient was readmitted due to two focal epileptic seizures with a duration of 1.5 minutes each.The seizures were self-limited and the patient was awake during the seizures with a gcs of 15, but he presented postictal after the seizures.In the hospital, the patient was observed having further focal epileptic seizure activity.He received levetiracetam and his daily dose of levetiracetam was increased to 1500 mg two times daily.The patient was seizure free for 24 hours and was discharged in his habitual state on (b)(6) 2021.Per the patient's physician, the primary cause of the events is suspected to be tumor progression.However, it could not be excluded that the skull remodeling surgery and/or in combination with optune might have aggravated the condition.

Manufacturer Narrative

Novocure medical opinion is that the cerebrospinal fluid leakage was related to the underlying disease (gbm) and unrelated to optune therapy.Cerebrospinal fluid leakage was reported in the optune therapy arm of the pivotal ef-11 recurrent gbm trial only (1%).

• 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: 12953147
• MDR Text Key: 285742898
• Report Number: 3010457505-2021-00193
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 12/07/2021

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: TFH9100EU
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LEVETIRACETAM; METHYLPREDNISOLONE; PANTOPRAZOL; PARACETAMOL; TRAMADOL
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male