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 Codes	Fall (1848); Strangulation (2084)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that based on the available information, the contribution of the optune gio device to the event cannot be ruled out.Fall is an expected event with device use (ef-11 4% and 8% ef-14 optune arm).Strangulation was not reported during ef-11 or ef-14 pivotal trials.Strangulation has been considered in the optune risk evaluation; initial risk was reduced as much as possible and residual risk is considered to be acceptable.The event did not result in permanent impairment of body function or permanent damage to a body structure.The event was considered temporary, the patient did recover from the event without reported sequelae.There are no long range health consequences to be expected.
Event or Problem Description
A 67-year-old male patient with glioblastoma (gbm) began optune gio therapy on(b)(6) 2023.On december 13, 2023, novocure received the reply regarding a patient survey conducted by an agency on behalf of novocure.In the survey, the patient reported the transducer array cords "choked" him which resulted in a fall that restricted his air supply.The patient was brought to the emergency room by ambulance.The date of event occurrence is unknown.No further details or causality assessment from the prescriber is available.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• 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: 18483502
• Report Number: 3010457505-2024-00253
• Device Sequence Number: 2844954
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/10/2024

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
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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: ATORVASTATIN; DEXAMETHASONE; ESCITALOPRAM; FAMOTIDINE; LEVETIRACETAM; LOMUSTINE; MELOXICAM; NITROGLYCERIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male