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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On september 12, 2022, novocure received the reply of a patient in regards to a patient survey conducted by an agency on behalf of novocure.Patient is a 67 year old male, who began optune therapy on (b)(6), 2022.In the survey, the patient reported the device hindered his mobility and the battery pack was very heavy.Reportedly, he dropped the device on his foot, which caused a major injury that required surgery.Date of event occurrence is unknown.After several attempts of contact, prescribing physician did not reply.No further details and no causality assessment from the prescriber is available.
Additional Manufacturer Narrative
Novocure opinion is that a contribution of the device to the the limb injury cannot be ruled out.Limb injury is not an expected event with device use in the pivotal ef-11 recurrent gbm trial.There have been 60 reports of limb injury in the commercial program to date.
Additional Manufacturer Narrative
On june 27, 2023, novocure discovered that the initial submitted medical device report (mdr) listed the manufacture report number incorrectly.The correct mdr number is 3010457505-2023-00220.

• 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: 16152546
• Report Number: 3010457585-2023-00220
• Device Sequence Number: 20596035
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/24/2023

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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: ACETAMINOPHEN; DEXAMETHASONE; ENOXAPARIN; LEVETIRACETAM; ONDANSETRON; PROCHLORPERAZINE MALEATE; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 119 KG