MAUDE Adverse Event Report: NOVOCURE LTD NOVOTTF-100A

Model Number TFH-9000

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

Patient Problem Death (1802)

Event Date 10/23/2013

Event Type  Death  

Event Description

Patient with recurrent glioblastoma started novottf therapy on (b)(6) 2013.Novocure was informed that the patient died.Date of death was (b)(6) 2013.Per nurse at the prescribing site, cause of death was gbm progression, not related to novottf therapy.Patient had a rapidly progressing disease and died in hospice so no hospital summary was available.No adverse events associated with device use were reported.The last date of novottf therapy was not known until the equipment was returned to novocure and logfiles downloaded on (b)(6) 2013.Per logfile review, last device use was (b)(6) 2013, at 15:34 and device was functioning as per normal operating conditions.

Manufacturer Narrative

Novocure concurs with nurse at the prescribing site that death was related to glioblastoma.Death was not related to notify therapy.Death is an expected event in patients with recurrent glioblastoma due to the natural history of the disease.On the pivotal phase iii trail overall survival was 6.3/6.4 months in the novottf therapy and chemotherapy arm respectively.This event will be reported to the fda as per novocures standard operating procedures which state that any death that occurs within 24 hours of device use be reported (patient was wearing device on day of death).

• Brand Name: NOVOTTF-100A
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg, shaar hacarmel; 4th floor; haifa 31905 ; IS 31905 ; 8501204
• MDR Report Key: 3590979
• MDR Text Key: 4162854
• Report Number: 3009453079-2014-00035
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2013

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: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 47 YR
• Patient Weight: 132