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 Code	Wound Dehiscence (1154)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 72-year-old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2021.Novocure was informed on february 17, 2023, that the patient developed an open area with exposed cranial hardware at the surgical resection site (last surgical resection (b)(6) 2021).In available medical records, the prescribing physician noted on (b)(6) 2023, an open wound with exposed hardware developed in (b)(6) 2023, however the patient did not report to the physician and continued to place arrays over the affected area.Treatment included a ten day course of antibiotics (cephalexin 500mg qid).On (b)(6) 2023, the patient made novocure aware she had recurrent surgery scheduled for that week.On (b)(6) 2023, the healthcare provider reported, the patient experienced disease progression, had evidence of wound dehiscence and exposed cranial hardware without infection.The patient underwent a left craniotomy and removal of cranial hardware on (b)(6) 2023.Optune therapy was discontinued.Per the prescriber, optune therapy contributed to the event.
Additional Manufacturer Narrative
Novocure opinion is that the 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 surgeries 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.

• 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: 16762926
• Report Number: 3010457505-2023-00234
• Device Sequence Number: 19598517
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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: APIXABAN.; FERROUS GLUCONATE.; HYDROCHLOROTHIAZIDE.; LEVETIRACETAM.; LORAZEPAM.; LOSARTAN.; PANTOPRAZOLE.; PRAMIPEXOLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG