MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH9100

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

Patient Problems Fall (1848); Limb Fracture (4518); Multiple Fractures (4519)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that optune possibly contributed to the fall by affecting patient's balance.Fracture was secondary to fall.Fall 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 (8% and 3% in optune/tmz and tmz arms respectively).Femur fracture 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.

Event Description

A (b)(6) year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2021.On (b)(6) 2021, novocure was informed by the sister that the patient was hospitalized following a fall and a fractured femur.Optune therapy was temporarily discontinued during the hospital stay.The fall occurred when the patient exited her bed, reached for the optune device, placed it in the side satchel bag over her shoulder, lost her balance and fell backward.On (b)(6) 2021, the sister reported that the patient had been discharged on an unspecified date to a rehabilitation facility.Prescribing physician was unable to provide a causality assessment to the event.

Manufacturer Narrative

On (b)(6) 2021, novocure discovered additional information within a medical record that on (b)(6) 2021, when the patient fell she also sustained a rib fracture.On (b)(6) 2021, the patient was admitted to the hospital and underwent internal fixation surgery with three screws to repair the left femur fracture.On (b)(6) 2021, the patient was discharged home from rehabilitation and resumed optune therapy.Rib fracture 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.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• MDR Report Key: 11330031
• MDR Text Key: 235012428
• Report Number: 3009453079-2021-00164
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

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: 01/19/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; BEVACIZUMAB; CEPHALEXIN; CLOBETASOL TOPICAL 0.05%; DEXAMETHASONE; LEVETIRACETAM; MELATONIN; MUPIROCIN TOPICAL 2%; SULFAMETHOXAZOLE-TRIMETHOPRIM; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 64