MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Electric Shock (2554); Convulsion/Seizure (4406)

Event Date 10/24/2023

Event Type  Injury  

Event Description

A 56-year old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2023.During treatment initiation that day, the patient reported to a novocure representative, that she experienced an electric sensation described as "zapping".Upon restarting therapy, it was discovered that one of the transducer array cables was not connected correctly to the connector of the field generator, which resulted in another "electrical shock" sensation.The patient continued with optune therapy.On october 25, 2023, the patient's caregiver reported the patient had experienced a consistent headache in the region of the previous electrical sensation.Emergency medical services (ems) was called and the patient was admitted to the hospital following two seizures.The patient remained hospitalized due to the seizures and headaches that initiated on the evening of (b)(6) 2023.On (b)(6) 2023, the healthcare provider (hcp) confirmed that the patient had a history of seizures, dating back to 2015, the most recent seizure was on the day of optune therapy start.The patient was prescribed levetiracetam 500mg bid, which was increased to 750mg.The patient was discharged on (b)(6) 2023, in stable condition.The hcp stated that they believe the event was caused by the optune device, as seizure and headache occurred after the electric sensations.

Manufacturer Narrative

Novocure medical opinion is that the electric sensation was caused by device use, and the contribution of the optune device to the seizure cannot be ruled out.The logfile could not be reviewed as device was not returned back to the manufacturer.There have been no prior reports of patients being seriously injured or permanently injured or requiring treatment as a result of an electric sensation.Electric sensation is an expected event associated with device use and most commonly occurs when there is insufficient array to scalp contact (hair growth, insufficient shaving prior to placement of arrays, significant head sweating or lifting of the medical adhesive bandages holding arrays in place).Patient had a history seizures prior to start of optune therapy.Additional 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).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).

• 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: 18225365
• MDR Text Key: 329195921
• Report Number: 3010457505-2023-00250
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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: CALCIUM CARBONATE; DEXAMETHASONE; FERRIC DERISOMALTOSE; LEVETIRACETAM; METOPROLOL TARTRATE; ONDANSETRON; OXYCODONE; PANTOPRAZOLE; PROCHLORPERAZINE MALEATE; PROMETHAZINE; SULFAMETHOXAZOLE/TRIMETHOPRIM; TEMOZOLOMIDE; TOPIRAMATE; VITAMIN B-12
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female