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); Vertebral Fracture (4520)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the fall and spinal compression fracture were related to optune due to the involvement of the device cord in the mechanical fall.Fall is an expected event with device use and was reported as an adverse event in the (b)(6) 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).Spinal compression fracture is an expected event with device use and was reported in the (b)(6) trial in both arms of the trial (<1% and 1% in optune/tmz and tmz arms respectively).

Event Description

A (b)(6) year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019.On (b)(6) 2020, novocure was informed by the spouse that the patient had fallen on an unspecified date after becoming tangled in the optune wires.Per medical records, after experiencing a fall and back pain of three weeks duration, patient underwent spine x-ray on (b)(6) 2020, that revealed moderate to prominent vertebral body compression at t7 and mild vertebral body compressions at t5 and t6.Patient continued with optune therapy at low usage (19%).Patient was treated with trigger point steroid injections for pain.On (b)(6) 2020, repeat mri of the cervical and lumbar spine was neative for fracture.Mri of the thoracic spine demonstrated subacute t7 compression fracture predominantly at the superior endplate with a height decrease of 50%.Patient denied any pain.Patient was not hospitalized for the event.Prescribing physician did not assess the relationship of the event to optune.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer (Section G): NOVOCURE, LTD.; 195 commerce way; portsmouth NH 03801
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 6033191907
• MDR Report Key: 10659143
• MDR Text Key: 215512082
• Report Number: 3009453079-2020-00160
• 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: 10/09/2020

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
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 104