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	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factor for wound dehiscence 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, 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 or Problem Description
A 66 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2022.Novocure was informed on (b)(6) 2023, that during a transducer array change, the patient observed what appeared as exposed cranial hardware on the scalp in the location of previous surgery.An image provided, revealed exposed cranial hardware on the surgical resection scar (last surgical resection (b)(6) 2022).On (b)(6), 2023, the patient's caregiver reported the patient had surgery to remove four plates and a bone.Optune therapy was temporarily discontinued.According to the discharge summary provided by the prescribing physician, the patient was hospitalized on (b)(6) 2023, for elective surgery to remove exposed cranial hardware of the right parietal cranial plates, irrigation, and debridement of the right parietal scalp.Infectious disease was consulted and antibiotics (ceftriaxone and daptomycin) were administered via a peripherally inserted central catheter (picc) line.The postoperative course was uncomplicated, and the patient was discharged home in good condition on (b)(6) 2023.On (b)(6) 2023, the prescriber assessed the event as related to optune therapy.

• 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: 17184923
• Report Number: 3010457505-2023-00239
• Device Sequence Number: 17766075
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/22/2023

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: 05/24/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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: ALENDRONATE SODIUM.; GABAPENTIN.; LEVETIRACETAM.; LEVOTHYROXINE.; LOSARTAN SODIUM.; MEGESTROL ACETATE.; PANTOPRAZOLE.; TEMOZOLOMIDE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 53 KG