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 04/25/2015

Event Type  Death  

Event Description

Pt with glioblastoma (gbm) began optune therapy on (b)(6) 2015, novocure was informed by pt's spouse that the pt died earlier that morning.Prescribing physician was contacted for add'l info with no response.Cause of death is unk.No adverse events associated with device use were reported.The last day of optune therapy was not known until the equipment was returned to novocure and logfiles downloaded on (b)(6) 2015.Per logfile review, last device use was (b)(6) 2015 at 09:56 and device was functioning as per normal operating parameters.

Manufacturer Narrative

Novocure medical opinion is that the death was not related to optune therapy.Death is an expected event in pts with glioblastoma (gbm) due to the natural history of the disease.Pts with newly diagnosed gbm who are treated with maximal surgical resection, 60 gy radiotherapy together with temozolomide, followed by maintenance temozolomide for 6 months have a median survival of 14.6 months [stupp et al n engl j med 352 (10): 987-96, 2005].

• 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: 4807951
• MDR Text Key: 20362684
• Report Number: 3009453079-2015-00056
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TFH-9000
• Other Device ID Number: 07290107980401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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: 66 YR
• Patient Weight: 84