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 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Novocure' s opinion is that a contribution of the array placement to the wound infection cannot be ruled out.Wound infection 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 both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

A 58-year-old female with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6), 2023.On (b)(6), 2023, novocure was informed that the patient experienced a headache for approximately three days and optune therapy was temporarily discontinued.During an appointment at the hospital, it was discovered the patient's surgical wound was infected which resulted in hospital admission for surgery.On (b)(6), 2023, the patient's spouse confirmed that the patient underwent a craniotomy on (b)(6), 2023, due to a wound infection.The physician reported on (b)(6), 2023, that the patient experienced itching at the surgical resection site in (b)(6) 2023.It was noted the patient scratched the wound which resulted in the area becoming infected.The craniotomy conducted on (b)(6), 2023, consisted of removal of bone fragment, epidural abscess, and staphylococcus aureus was detected.The physician assessed that optune therapy contributed to the event.

• 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: 18082782
• MDR Text Key: 327476738
• Report Number: 3010457505-2023-00249
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: TFH9100JP
• Device Lot Number: N/A
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female