MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Ulcer (2274)

Event Date 02/27/2023

Event Type  Injury  

Event Description

A 70 year old male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2021.On (b)(6) 2022, it was reported the patient temporarily discontinued optune therapy on (b)(6) 2022, due to an unspecified injury.Additionally, there was a non-healing wound near the surgical resection scar (last surgical resection, unknown).On (b)(6) 2022, and on (b)(6) 2023, the caregiver reported the wound from september 2022, had not healed, however the patient continued with optune therapy and monitored the affected area.Novocure was informed on (b)(6) 2023, the patient was hospitalized due to an infected ulcer on the scalp that required surgery.No additional information was provided.No causality assessment from the prescriber is available.

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Medical device site ulcer 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 the optune arm of the trial (1%).

Manufacturer Narrative

On february 28, 2023, novocure received additional information from the prescribing physician that the contributing factors that led to the patient's condition were skin thinning due to surgery, radiation therapy and delayed wound healing due to chemotherapy (bevacizumab).The physician's causality assessment did not report optune as a contributing factor although, novocure's medical opinion is that a contribution cannot be ruled out.

• 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: 16612027
• MDR Text Key: 311960659
• Report Number: 3010457505-2023-00233
• Device Sequence Number: 1
• Product Code: NZK
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: TFH9100JP
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• 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: BEVACIZUMAB.; NOT PROVIDED.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male