MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure opinion is that a contribution of the array placement to the impaired healing of the wound complication cannot be ruled out.The fall and cerebral hemorrhage are unrelated to optune gio therapy.Contributing factors for impaired healing in this patient include prior lomustine (carries a black box warning for myelosuppression.Source: lomustine prescribing information), prior radiation, chemotherapy, prior surgery affecting the skin integrity and underlying gbm disease.Impaired healing is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).Additional notes: manufacturing date of (b)(6) is november 06, 2019, and manufacturing date of (b)(6) is july 14, 2019.
Event or Problem Description
A 57-year-old male patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2017.Novocure was informed on january 22, 2024, that the patient fell and sustained a cerebral hemorrhage that required surgery.On (b)(6) 2024, the patient reported that he had surgery on an unspecified date due to a wound complication at a previous surgical site.The healthcare provider (hcp) advised to temporarily discontinue optune gio therapy.The patient reported on (b)(6) 2024, that he resumed optune gio therapy.The hcp reported on (b)(6) 2024, the patient fell on stairs, and had a brain bleed that required surgery, and the wound did not heal correctly.The cause of the event was the previous fall and secondary brain bleed.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 19592052
• Report Number: 3010457505-2024-00291
• Device Sequence Number: 8493795
• Product Code: NZK
• UDI-Device Identifier: 07290107982214
• UDI-Public: (01)07290107982214(11)170105
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2017
• 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: BOSWELLIC ACID; LACOSAMIDE; LEVETIRACETAM; METFORMIN; METHYLPHENIDATE; MIRTAZAPINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 77 KG