MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ulcer (2274); Skin Infection (4544)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 67 year old male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2020.On may 10, 2023 novocure received information that patient required wound debridement of infected skin ulcerations beneath the ine transducer arrays.According to available medical records, patient experienced ulcerations on the scalp beneath the transducer arrays starting in (b)(6) 2022.The physician advised the patient to temporarily discontinue optune therapy.Therapy was resumed (b)(6) 2022.During a follow-up visit on (b)(6) 2023, per progress note, patient had temporarily discontinued optune therapy for approximately three weeks due to skin breakdown/irritation.The scalp healed, and the patient resumed optune therapy.However, after one week, the skin breakdown and irritation recurred.The physician observed ulcerations under the transducer arrays and noted a progressive scalp infection with malodor.Treatment included a topical antibiotic (clindamycin), oral (doxycycline), and a referral for outpatient home wound care.According to the device log records, patient temporarily discontinued optune therapy (b)(6) 2023.On (b)(6) 2023, during a follow-up office visit, the physician noted multiple, foul-smelling and infected areas on the scalp.The patient presented for wound care on (b)(6) 2023, and was found to have a partial thickness wound on the scalp assessed as caused by the wear of the optune device.The wound, was covered by dried eschar, non-viable slough, and some adherent exudate.The patient underwent surgical wound debridement of the necrotic tissue.The patient continued to experience impaired wound healing due to exudate production and moderate to copious drainage, therefore continued with skilled wound clinic care.On (b)(6) 2023, the patient's spouse reported the patient had been intermittently using the therapy due to ongoing wound care routines and has since resumed optune therapy.The caregiver mentioned that it is ensured nothing is covering the wound areas.Per available device log records, patient temporarily discontinued optune therapy on (b)(6) 2023 and resumed therapy (b)(6) 2023.
Additional Manufacturer Narrative
Novocure agrees with the treating physician that the array placement contributed to medical device site ulcer and skin infection.Novocure opinion is, that device use despite existing complications possibly contributed to a worsening of the events.Contributing factors for medical device site ulcer and skin infection in this patient include: prior bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information), lomustine (carries a black box warning for myelosuppression.Source: lomustine prescribing information), prior radiation, prior chemotherapy, underlying cancer disease, and prior 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.Skin 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).

• Brand Name: OPTUNE
• Common Device Name: 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: 17082825
• Report Number: 3010457505-2023-00237
• Device Sequence Number: 6244114
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CITALOPRAM; LACOSAMIDE; LEVETIRACETAM; LOMUSTINE; METFORMIN; NORTRIPTYLINE; NOVOLIN INSULIN; PHENYTOIN; TAMSULOSIN; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 78 KG