MAUDE Adverse Event Report: NOVOCURE LTD NOVOTFF-100A

Model Number TFH-9000

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

Patient Problem Death (1802)

Event Date 05/03/2014

Event Type  Death  

Event Description

Patient with recurrent glioblastoma began novottf therapy on (b)(6) 2014.On (b)(6) 2014 a novocure device support specialist was informed by the son that the patient passed away on (b)(6) 2014.The patient was admitted to hospital for pneumonia prior to death but the family did not know the official cause of death.Prescribing physician was contacted for additional information with no response.Cause of death is unknown.No adverse events associated with device use were reported.The last of novotff therapy was not known until the equipment was returned to novocure and logfiles downloaded on (b)(4) 2014.Per logfile review, last device use was (b)(6) 2014 at 05:37 and device was functioning as per normal operating parameters.

Manufacturer Narrative

Novocure medical opinion is that the death was not related to novotff therapy.Death is an expected event in patients with recurrent glioblastoma (gbm) due to the natural history of the disease.(b)(4).

• Brand Name: NOVOTFF-100A
• 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: 3958223
• MDR Text Key: 16991779
• Report Number: 3009453079-2014-00041
• 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: 06/26/2014

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: 06/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• 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: 66 YR
• Patient Weight: 91