MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2022

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 307260893
• Report Number: 3010457585-2023-00220
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; DEXAMETHASONE; ENOXAPARIN; LEVETIRACETAM; ONDANSETRON; PROCHLORPERAZINE MALEATE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 119 KG