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 01/31/2014

Event Type  Death  

Event Description

Pt with recurrent glioblastoma began novottf therapy on (b)(6) 2014.The pt's spouse reported that the pt had been hospitalized due to left side weakness and tumor progression.On (b)(6) 2014, prescribing physician reported that the pt had been discharged on (b)(6) 2014 to hospice with plans to continue novottf therapy while in hospice.Pt died on (b)(6) 2014 after experiencing chest pain.Pt's medical history was significant for coronary artery disease and angina.Per prescriber, death was not related to novottf therapy.Immediate cause of death was unk.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) 2014.Per logfile review, last device use was (b)(6) 2014, at 04:00 and device was functioning as per normal operating parameters.

Manufacturer Narrative

Novocure concurs with prescriber that death was not related to novottf therapy.Death was most likely related to glioblastoma progression or coronary artery disease.Death is an expected event in pts with recurrent glioblastoma due to the natural progression of the disease.On the pivotal phase iii trial overall survival was 6.3/6.4 months in the novottf therapy and chemotherapy arm respectively.

• Brand Name: NOVOTTF-100A
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg, sha'ar hacarmel; 4th fl; haifa 31905 ; IS 31905
• MDR Report Key: 3788199
• MDR Text Key: 4441727
• Report Number: 3009453079-2014-00038
• 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: 04/02/2014

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: 04/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2012
• 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
• Treatment: LOSARTAN; RANITIDINE; AMLODIPINE; ASPIRIN; MIRTAZAPINE; PROCHLORPERAZINE; ONDANSETRON; METOPROLOL TARTRATE; ALPRAZOLAM; RANOLAZINE; PRAVASTATIN; NITROGLYCERIN; ISOSORBIDE MONONITRATE; TOPIRAMATE
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 57