MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9000

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

Patient Problem Death (1802)

Event Date 10/30/2014

Event Type  Death  

Event Description

Patient with recurrent glioblastoma began optune treatment on (b)(6) 2014.On (b)(6) 2014, patient was hospitalized for general physical health deterioration.On (b)(6) 2014, novocure was informed that the patient had died that same day.No additional information was provided.No adverse events associated with device use were reported.Per device logfile review, the last day of optune use was (b)(6) 2014 at 07:40 and device was functioning as per normal operating conditions.On (b)(6) 2014, prescribing physician informed novocure that the patient had been lost to follow-up and had not been seen at the clinic since the optune therapy initiation visit.Therefore, cause of death was not known and a causality assessment was not provided.

Manufacturer Narrative

Novocure medical opinion is that the death was not related to optune.Death is an expected event in patients with recurrent glioblastoma (gbm) due to the natural history of the disease.On the pivotal phase iii trial, overall survival was 6.3/6.4 months in the optune and chemotherapy arms respectively.

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg, sha'ar hacarmel; 4th floor; haifa 31905 ; IS 31905 ; 48501204
• MDR Report Key: 4431649
• MDR Text Key: 17275490
• Report Number: 3009453079-2015-00047
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/28/2014

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: TFH-9000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2014
• Initial Date FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 37 YR