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 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the contribution of the optune gio device use to the fall and secondary humerus fracture cannot be excluded.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 60-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.During the review of an available medical record, it was discovered that the patient notified the prescribing physician, during a follow up visit on (b)(6) 2023, that she experienced a fall at home and was evaluated in the emergency department (ed).Reportedly, the patient was mopping the floor and became entangled in the cord from the optune gio device.Examination in the ed revealed a humerus fracture.The patient ended optune gio therapy on (b)(6) 2023.The prescribing physician was contacted for further details without reply.

• 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: 18992439
• MDR Text Key: 338810817
• Report Number: 3010457505-2024-00265
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)171221
• 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: 03/28/2024

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 Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2017
• 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: ACETYLSALICYLIC ACID; BEVACIZUMAB; LACOSAMIDE; LEVETIRACETAM; ONDANSETRON; PANTOPRAZOLE; PROCHLORPERAZINE; SENNOSIDES; SERTRALINE; TRAZODONE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female