MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9100

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

Patient Problems Contusion (1787); Fall (1848); Bone Fracture(s) (1870)

Event Date 06/25/2017

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the fall and subsequent fractures and contusions were related to optune due to the involvement of the device cord in the mechanical fall.Fall is a known event with device use and was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (8% and 3% in optune/tmz and tmz arms respectively).

Event Description

A (b)(6) patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017.On (b)(6) 2017, it was reported that the patient had been admitted to the hospital the previous day following a fall that morning.The patient reported that they were walking to the bathroom, tripped on the device cad (i.E., the connection cable and box, specifically the cable which runs between the electric field generator/"the device" and the array wires), and fell backwards.The patient suffered a compression fracture, several broken ribs, and bruises on her legs and back.The patient was treated with po pain medication (morphine).The patient temporarily discontinued optune therapy use upon admission, but planned to restart therapy during the hospitalization.Prescribing physician was contacted for additional information with no response.

Manufacturer Narrative

Novocure is submitting a follow up mdr to correct information.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; haifa 31905
• Manufacturer (Section G): NOVOCURE LTD; topaz building, sha'ar; hacarmel 4th floor; hafia, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz biulding, sha'ar; hacarmel 4th floor; haifa 31905
• MDR Report Key: 6727985
• MDR Text Key: 80544534
• Report Number: 3009453079-2017-00088
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

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
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2016
• 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: DEXAMETHASONE; PRAVASTATIN; TEMOZOLOMIDE; ZOLPIDEM
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 64