MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the contribution of the optune gio device to the fall and secondary humerus fracture cannot be ruled out.Fall is an expected event with optune gio device use (ef-11 4% and 8% ef-14 optune arm).Humerus fracture was not reported as an expected event with optune gio device use in the (ef-11 or ef-14 trial in optune arm).There have been approximately 4 reports of humerus fracture in the commercial program to date.

Event Description

A 68-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2022.On (b)(6) 2023, the patient's spouse informed novocure that a few days prior, while the patient was carrying the optune gio device on his back he lost his balance and fell.The patient was brought to the hospital where an x-ray confirmed a humerus fracture.On (b)(6) 2023, the attending physician reported that a causal relationship between the fall and the loss of balance due to the weight of the optune gio device was possible, although the injury did not result in hospitalization and deemed non-serious.The physician noted the patient did not experience dizziness or light-headedness and was prescribed no concomitant medications that would contribute to the event.The patient ended optune gio therapy on (b)(6) 2023.

• Brand Name: OPTUNE GIO
• Type of Device: OPTUNE GIO
• 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: 19010030
• MDR Text Key: 338981127
• Report Number: 3010457505-2024-00266
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982238
• UDI-Public: (01)07290107982238(11)190113
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100JP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2019
• 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: NOT PROVIDED.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female