MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Cognitive Changes (2551)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that cognitive disorder is not related to optune therapy but related to underlying disease (gbm) and radiation.Cognitive disorder was reported on the pivotal ef-11 recurrent gbm trial as an adverse event in both arms of the trial (2% optune therapy vs.2% chemotherapy arm).Cognitive disorder is a common symptom of underlying disease (recurrent gbm).

Event Description

A (b)(6) male patient with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2017.On september 01, 2021, the patient's healthcare provider reported that the patient was hospitalized from (b)(6) 2020, until (b)(6) 2020, due to increased cognitive disorder.Optune therapy was discontinued.Per clinical evaluation, the patient experienced neurodegenerative alzheimer-like disease associated with radiation leukoencephalopathy.The patient received palliative care.During a follow-up appointment on (b)(6) 2021, the patient presented disorientated in time and space, with aphasia, bilateral lower limb edema, generalized coma and karnofsky performance score of 40%.The patient denied headaches.An mri from (b)(6) 2020, showed stable tumor, leukoencephalopathy and cortical atrophy.Per the patient's physician, the alzheimer's disease seemed plausible in regards to the patient's age but he could not exclude a relation between the cognitive disorder and optune therapy.The physician stated that the cognitive disorder was present prior to optune therapy and can be linked to tumor disease and side effects of treatment.

• 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: 12540023
• MDR Text Key: 273563551
• Report Number: 3009453079-2021-00185
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/28/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/28/2021
• Date Device Manufactured: 01/18/2016
• 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: ACEBUTOLOL; ACETYLSALICYLIC ACID LYSINE; AMLODIPINE; ESCITALOPRAM; FOLATE; LACOSAMIDE; LANSOPRAZOLE; LEVETIRACETAM; METFORMIN; QUETIAPINE; TEMOZOLOMIDE; VALSARTAN
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 73