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); Bone Fracture(s) (1870); Vertebral Fracture (4520)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the fall, femur fracture, and vertebrae fractures treated in the (b)(6) 2020, hospitalization were related to optune due to the involvement of the transducer array cords in the mechanical fall.Prior falls were not related to optune.Fall is an expected 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).Vertebrae fracture (spinal compression fracture), is an expected event with device use and was reported in the ef-14 trial in both arms of the trial (<1% and 1% in optune/tmz and tmz arms respectively).Femur 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 optune/tmz arm of the trial (<1%) only.

Event Description

A (b)(6) year old female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.Per medical record review, on (b)(6) 2020, prescriber noted that after the 2nd chemotherapy (temozolomide) treatment, the patient experienced nausea, imbalance, stumbling, and veered to the right or left.No falls were reported.During the week of (b)(6) 2020, patient was started on a corticosteroid medication (dexamethasone 1 mg daily) and tolerated it well.On (b)(6) 2020, during a virtual follow-up visit, the prescriber noted that the patient became confused, and had several recent falls.Dexamethasone was increased to 4 mg daily with improvement and tapered to 2 mg daily with continued improvement.On (b)(6) 2020, the patient fell at home.On (b)(6) 2020, the patient underwent a pelvic mri.The results were consistent with acute or subacute non-displaced fractures of the left superior and inferior pubic remi, the left pubic bone, and the left sacral alar.During a virtual follow-up patient visit on (b)(6) 2020, the prescriber stated the pelvic fracture had healed and the patient had been walking independently.No recent falls were reported.On (b)(6) 2020, novocure received additional information from the spouse stating that on (b)(6) 2020, the patient had been hospitalized following a fall.The spouse reported that after the patient set down the optune device in the carrying case, she inadvertently walked away and was pulled backward from the attached transducer arrays, causing the patient to fall.Patient was treated for a femur fracture and 4 vertebrae fractures.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: 11077293
• MDR Text Key: 223799737
• Report Number: 3009453079-2020-00162
• 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: 12/28/2020

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: TFH-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2016
• 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: DEXAMETHASONE; FAMOTIDINE; GRANISETRON; ONDANSETRON; PROCHLORPERAZINE; SUMATRIPTAN; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR