MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH9100

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

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician, that the event was caused by the patient tripping over the device cord.Other contributing factors include: history of frequent falls, muscular weakness, peripheral edema and left sided hemiparesis.Hip fracture 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 the tmz arm of the trial (<1%) only.

Event Description

A (b)(6) male with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018.On (b)(6) 2018, the patient's brother reported that the patient had fallen and broke his hip on (b)(6) 2018.The patient was hospitalized and required hip surgery.On (b)(6) 2018, the prescribing physician confirmed that the patient's hip fracture was caused by tripping over the optune device cord.At the time of the report, the patient was in rehab and was continuing optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa 31905 ; 9724850120
• MDR Report Key: 7677960
• MDR Text Key: 113672769
• Report Number: 3009453079-2018-00103
• 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
• Report Date: 07/11/2018

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: TFH9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 11 MO
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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: AMLODIPINE; DEXAMETHASONE; FAMOTIDINE; LEVETIRACETAM; ONDANSETRON; TEMOZOLOMIDE; TRAZODONE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 73