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	Abscess (1690); Post Operative Wound Infection (2446)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's opinion is that a contribution of the array placement to the wound infection and abscess cannot be ruled out.Contributing factors for wound infection and abscess in this patient include, prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, chemotherapy, and prior surgeries affecting skin integrity.Wound 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).Abscess is an expected event with device use and was reported in the ef-14 trial in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).
Event or Problem Description
A 66-year-old male with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.On (b)(6) 2022, novocure received a report that the patient was hospitalized and scheduled for an unspecified surgery later that day.Per hospital summary provided, on (b)(6) 2022, the patient was admitted to the hospital for evaluation of yellow drainage from a head wound.Wound cultures grew serratia and the patient was prescribed antibiotics (cefepime 2 grams every 12 hours).On (b)(6) 2022, the patient was discharged home.On (b)(6) 2022, the patient presented to the emergency room with altered mental status, fever (102f), lethargy and incisional wound breakdown with purulent discharge (last surgical resection (b)(6) 2021).The patient underwent a right frontal craniectomy and evacuation of intracerebral abscess and removal of artificial cranial flap, with plastic surgery assisting with closure.There were no complications.Superficial and deep wound cultures were positive for staphylococcus epidermidis and methicillin-susceptible staphylococcus aureus.A left peripherally inserted central catheter (picc) line was placed for long-term antibiotic therapy (vancomycin and nafcillin).On (b)(6) 2022, the patient was discharged in stable condition to a rehabilitation facility.Optune therapy was discontinued.No causality assessment was provided from the prescriber.

• 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: 15901441
• Report Number: 3010457505-2022-00221
• Device Sequence Number: 5016315
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/01/2022

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
• 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: 10/27/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2020
• 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: ALOGLIPTIN; ASPIRIN; BROMOCRIPTINE; DEXAMETHASONE; GLIMEPIRIDE; LEVETIRACETAM; METFORMIN; METOPROLOL SUCCINATE; ONDANSETRON; OXYCODONE; PANTOPRAZOLE; ROSUVASTATIN; TADALAFIL; TEMOZOLOMIDE; VALSARTAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male