MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: prior radiation, underlying cancer disease and prior surgery affecting skin integrity.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).

Event Description

A 57-year-old male with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2022.During a review of an available medical record dated (b)(6) 2023, it was discovered the patient experienced wound breakdown at the right craniotomy site described as scabbing and exposed hardware (last surgical resection on (b)(6) 2021).The physician advised to temporarily discontinue optune gio therapy.During a follow-up visit on (b)(6) 2023, the physician noted a scab located over the healed incision site in the right temporal region with no active discharge or purulence.The physician agreed to resume optune gio therapy with continued observation.On (b)(6) 2023, the prescribing physician informed novocure that the patient had surgery scheduled with a neurosurgeon for scalp revision with plastic surgery.There was no wound infection, although cranial hardware was exposed.The prescribing physician assessed the cause of the event due to multiple surgeries and could not exclude a possible contribution of optune gio therapy to the event.Additionally, the patient was not compliant and wore the therapy inconsistently.Optune gio therapy was discontinued in lieu of the upcoming surgery.

• 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: 19077054
• MDR Text Key: 339775022
• Report Number: 3010457505-2024-00263
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)190731
• 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 Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2019
• 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: EZETIMIBE; LEVETIRACETAM; METOPROLOL; ROSUVASTATIN CALCIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 57 KG