MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problem Fall (1848)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescriber that the fall was related to optune therapy.Fall was reported as an adverse event in the ef-11 recurrent gbm pivotal trial (4% vs.0%, optune therapy vs.Chemotherapy; related 1% and 0% respectively).

Event Description

Patient is a (b)(6) male with recurrent glioblastoma who began optune therapy with concomitant bevacizumab on (b)(6) 2016.On september 1, 2016, spouse reported patient had experienced a fall while wearing the optune arrays.Patient was exercising at the time of the fall and the device was not plugged in.Cords of the arrays got caught on a weight rack and patient's head was pulled back hard enough to throw the patient to the ground.There was no loss of consciousness or seizure activity associated with the fall.Patient sustained a laceration on the corner of the head.Patient went to urgent care and received 14 staples.Patient was not hospitalized for the event.Physician advised patient to resume optune treatment in 2-3 days.Per the prescribing physician, the cause of the fall and injury was the optune array cords becoming entangled, causing the patient to trip and fall.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5997962
• MDR Text Key: 56405173
• Report Number: 3009453079-2016-00075
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/04/2016

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 2 MO
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• 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
• Treatment: BEVACIZUMAB; DEXAMETHASONE; LEVETIRACETAM; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86