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 10/04/2021

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to the event 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 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 (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2021.On (b)(6) 2021, the patient reported that he experienced what felt like a "burning pain" on the scalp under the transducer arrays.On (b)(6) 2021, the spouse reported that the patient had experienced skin lesions under the transducer arrays.On (b)(6) 2021, the patient again reported skin lesions under the arrays, which had healed.On october 04, 2021, the spouse informed novocure that on an unspecified date, the patient had been hospitalized for wound revision surgery and placement of a cranium plate (last surgical resection (b)(6) 2020).Optune therapy had been temporarily discontinued approximately three weeks prior to this event.On (b)(6) 2021, the spouse reported that the sutures had been removed on (b)(6) 2021.The prescribing physician did not provide a causality assessment for 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
• MDR Report Key: 12724038
• MDR Text Key: 282110832
• Report Number: 3009453079-2021-00188
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/29/2021

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: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; DEXAMETHASONE; LEVETIRACETAM; LISINOPRIL; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR