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 03/08/2022

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution of the array placement to the ulceration cannot be ruled out.Risk factors for medical device site ulcer in this patient include: prior radiation and surgery affecting skin integrity.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%).

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.On (b)(6) 2022, novocure received a report that during a transducer array change on (b)(6) 2022, the visiting nurse observed an ulcer with exposed cranial hardware on the patient's scalp.Optune therapy was temporarily discontinued.On (b)(6) 2022, the prescribing physician reported, the cause of the event was a combination of prior craniotomies (last surgical resection (b)(6) 2020), radiation therapy, and optune therapy.The event was assessed as serious as plastic surgery suggested surgery might be necessary.

• 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: 13950971
• MDR Text Key: 288208197
• Report Number: 3010457505-2022-00206
• 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: 03/30/2022

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
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT PROVIDED
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male