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	Arthralgia (2355)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 54-year-old male patient with newly diagnosed glioblastoma (gbm) began optune gio therapy on (b)(6) 2022.During review of an available patient medical record, on (b)(6) 2024, the patient reported that he developed a suspected pinched nerve and pain in his shoulder, related to carrying the optune gio battery pack.The patient was in physical therapy and transitioned to using a fanny pack for carrying the device.On (b)(6) 2024, the patient reported that a few months prior, due to the weight of the bag and wearing it cross-body, it caused a pinched nerve which resulted in eight weeks of physical therapy.Reportedly, the patient was doing much better and appreciated the new bag and ability to wear it on his waist.The prescribing physician was contacted for further details without reply.
Additional Manufacturer Narrative
Novocure opinion is that a contribution of device use to the temporary impairment of the shoulder due to arthralgia cannot be ruled out.Arthralgia is an expected event with optune gio device use (ef-11 0% and 9% ef-14 optune arm).
Additional Manufacturer Narrative
On june 18, 2024, novocure discovered that the awareness date in the initial submitted medical device report (mdr) was incorrect.The correct awareness date is june 06, 2024.

• 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: 19557779
• Report Number: 3010457505-2024-00288
• Device Sequence Number: 14636199
• Product Code: NZK
• UDI-Device Identifier: 07290107982214
• UDI-Public: (01)07290107982214(11)200714
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2020
• 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: BUSPIRONE; FLUOXETINE; LEVETIRACETAM; ONDANSETRON; PROCHLORPERAZINE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 108 KG