MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Dysphagia/ Odynophagia (1815); Paresis (1998); Speech Disorder (4415)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that paresis, dysarthria, and dysphagia were related to the underlying disease (gbm) and unrelated to optune therapy.Paresis was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only and is a known complication of the underlying disease (gbm).Dysarthria is an expected event with device use and was reported as an adverse event 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 (3% and 2% in optune/tmz and tmz arms respectively).Dysphagia is an expected event with device use and was reported as an adverse event 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 (3% and 3% in optune/tmz and tmz arms respectively).

Event Description

A (b)(6)-year-old male with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2020.On (b)(6) 2021, novocure received a report that the patient was hospitalized on (b)(6) 2021.While on vacation abroad the patient experienced acute onset right lower extremity weakness, dysarthria, and dysphagia.Optune therapy was temporarily discontinued.After receiving high dose steroids, the patient was medically transported to a hospital in the united states.Patient presented to the emergency department (ed) following two weeks of progressive neurologic symptoms starting with word-finding difficulty, right sided weakness, increased confusion, and dysphagia, which required hospitalization.Mri brain demonstrated increased size of left cingulate gyrus/corpus enhancing necrotic lesion.On (b)(6) 2021, the patient was transferred to neurosurgery and underwent left frontal subtotal resection surgery with pathology demonstrating prominent treatment changes and atypical cells (last tumor resection (b)(6) 2019).On (b)(6) 2021, the patient was discharged to acute rehabilitation services in stable condition.On (b)(6) health care provider (hcp) assessed the underlying cause of the events as related to radiation and possibly related to optune therapy.

• 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: 12360530
• MDR Text Key: 267901914
• Report Number: 3009453079-2021-00180
• 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
• Report Date: 08/24/2021

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: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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: DEXAMETHASONE; ESOMEPRAZOLE MAGNESIUM; EZETIMIBE; LEVETIRACETAM; ROSUVASTATIN; SULFAMETHOXAZOLE-TRIMETHOPRIM; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 90