MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE TUMOR TREATING FIELD; STIMULATOR, LOW ELECTRIC FIELD, TUMOR TREATMENT

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

Patient Problem Toxicity (2333)

Event Date 10/03/2018

Event Type  Injury  

Event Description

Pt involved in clinical trial (this event was reported also by study coordinators to the appropriate regulatory authority) with a parp inhibitor and an alkylating chemotherapy.She was also using optune device (tumor treating field).Her liver enzymes have been gradually increasing over the last 2-3 weeks, but the values spikes yesterday.This lead to her hospitalization.It was not likely to be related to device, as she had been wearing the device significantly longer than taking the study drug and chemotherapy.

• Brand Name: OPTUNE TUMOR TREATING FIELD
• Type of Device: STIMULATOR, LOW ELECTRIC FIELD, TUMOR TREATMENT
• Manufacturer (Section D): NOVOCURE LTD.
• MDR Report Key: 7951753
• MDR Text Key: 123492364
• Report Number: MW5080431
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 58