MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Wound dehiscence 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/tmz arm of the trial (<1%) only.

Event Description

A 70-year old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.On (b)(6), 2023, the spouse reported the patient had a non-healing wound, behind the left ear in the location of the previous surgical resection site (last surgical resection: unknown).Upon removal of the transducer arrays on the same day, cranial hardware (screw) was noted.Patient was advised to temporarily discontinue optune therapy.The healthcare provider reported the neurosurgeon was aware and surgical intervention might be required to remove the cranial hardware to allow the wound to heal.Reportedly, since the wound improved, the patient restarted optune therapy.After restarting the condition of the wound worsened.During a visit with the neurosurgeon on (b)(6) 2023, it was determined surgery was required to remove the hardware.The neurosurgeon advised discontinuing optune therapy.No causality assessment was provided by the prescribing physician.

• 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: 16617272
• MDR Text Key: 312010464
• Report Number: 3010457505-2023-00230
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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: TFH9100EU
• Device Lot Number: N/A
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female