MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/09/2023

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound infection cannot be ruled out.Contributing factors for wound infection in this patient include: prior radiation, prior chemotherapy, underlying cancer disease, and prior surgery affecting skin integrity.Wound infection is an expected event with device use and was reported as an adverse event in the (b)(4) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

A 63 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2020.The patient informed novocure on (b)(6) 2023, that she went to urgent care a few days prior due to an infected area on the scalp, where she received antibiotic treatment.The health care provider (hcp) advised temporarily discontinuing optune therapy.Patient reported, that on (b)(6) 2023, she went to the emergency department, due to another infected area on the scalp, which might require surgical intervention.On (b)(6) 2023, the patient reported she was in the hospital and scheduled for surgery the following day; patient underwent surgery for wound washout (last surgical resection was (b)(6) 2019).In the images provided, there appears to be an opening at the surgical resection site with exposed cranial hardware.Prescribing physician confirmed that the patient was hospitalized, underwent surgery for wound washout and closure and was treated with unspecified antibiotics.The prescribing physician assessed the cause of the event as possibly related to optune therapy.Patient temporarily discontinued optune therapy upon physician's instructions.

• 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: 16673430
• MDR Text Key: 312601119
• Report Number: 3010457505-2023-00232
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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
• Device Lot Number: N/A
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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: LEVETIRACETAM; MECLIZINE; MELOXICAM; MEMANTINE; METHIMAZOLE; OMEPRAZOLE; ONDANSETRON
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female