MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9100

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

Patient Problems Fall (1848); Seizures (2063); Skull Fracture (2077)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that optune did not contribute to the events.The fall which caused the skull fracture was secondary to a seizure which was related to disease progression.Seizures were reported as adverse events on the pivotal phase iii recurrent gbm trial in both arms of the trial (9% and 4% in optune therapy and chemotherapy arms respectively, none related).Fall is a known adverse event and is listed in the ifu (4% vs.0%, optune therapy vs.Chemotherapy; related 1% and 0% respectively).Skull fracture was not reported as an adverse event in the pivotal ef-11 recurrent gbm trial or in the commercial program to date.

Event Description

A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2016.On (b)(6) 2017, while on optune therapy, the patient experienced a new onset seizure and fell while at home.Patient was unresponsive and was transported by ambulance to the emergency room.Ct scan confirmed occipital fracture and right posterior lateral epidural hematoma.Patient was also found to have significant tumor progression.Patient was treated with 10 mg of dexamethasone (10 mg tid) and was discharged home on (b)(6) 2017.Per the prescribing physician, the events were related to gbm progression and were not related to optune.

• 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: 6348925
• MDR Text Key: 67946924
• Report Number: 3009453079-2017-00081
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/22/2017

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-9100
• 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: 5 MO
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• 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: CHROMIUM PICOLINATE; CUROUMIN; DEXAMETHASONE; LISINOPRIL; MAGNESIUM POTASSIUM ASPARTATE; PANTOTHENIC ACID; PHENYTOIN; PRAVASTATIN; TEMOZOLOMIDE; VITAMIN D3
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR