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); Hip Fracture (2349)

Event Date 03/13/2024

Event Type  Injury  

Event Description

A 67-year-old female patient with high grade glioma started optune gio therapy on (b)(6) 2023.On (b)(6) 2024, the patient's spouse informed novocure that on (b)(6) 2024, the patient tripped on the device cord and fell.The patient sustained a hip fracture and required hip replacement surgery.The patient's healthcare provider (hcp) notified novocure that the patient suffered a right femoral fracture and underwent a total right hip arthroplasty on (b)(6) 2024.The hcp noted that the patient denied loss of consciousness associated to the fall and currently was not experiencing disease progression.The event was assessed by the hcp as unrelated to optune gio therapy.

Manufacturer Narrative

Novocure's medical opinion is that the contribution of the device cord to the fall and secondary right femoral fracture cannot be ruled out.Fall is an expected event with optune gio device use (ef-11 4% and 8% ef-14 optune arm).Hip 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 75 reports of hip fracture in the commercial program to date.

• 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: 19077151
• MDR Text Key: 339774883
• Report Number: 3010457505-2024-00267
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)190411
• 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: 04/10/2024

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 Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2019
• 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: CHOLECALCIFEROL.; ENALAPRIL.; ESCITALOPRAM.; MULTIVITAMIN.; ONDANSETRON.; PROCHLORPERAZINE MALEATE.; ROSUVASTATIN.; TEMOZOLOMIDE.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 88 KG