MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Abrasion (1689); Fall (1848); Hematoma (1884); Intracranial Hemorrhage (1891); Limb Fracture (4518)

Event Date 04/22/2023

Event Type  Injury  

Manufacturer Narrative

Even though a relation of the device use to the fall was not mentioned by the reporter, novocure medical opinion is that a potential contribution of the device use to the fall and secondary injuries reported cannot be excluded.Patient used to place the optune device on a rollator to be able to move with the device and he fell while walking without the rollator.Subarachnoid hemorrhage, upper limb fracture, skin abrasion and hematoma were secondary to the fall.All events are expected events with device use and were reported as adverse events during the ef-14 trial of optune together with temozolomide: fall (8% and 3% in optune/tmz and tmz arms respectively), haematoma (1% and 1% in optune/tmz and tmz arms respectively), upper limb fracture (<1% and <1% in optune/tmz and tmz arms respectively), and skin abrasion (1% and 1% in optune/tmz and tmz arms respectively).Subarachnoid haemorrhage was reported in the optune/tmz arm of the trial (<1%) only.

Event Description

A 72-year-old male with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.On (b)(6) 2023, novocure was informed by the spouse that the patient was hospitalized the prior day due to a fall.Optune therapy was temporarily discontinued.According to discharge summary provided by the treating physician on (b)(6) 2023, the patient had been walking at home without assist of a walker or cane when he tripped and fell on his right side hitting his forehead sustaining a hematoma on the forehead as well as superficial abrasion to the forehead and to the right elbow.The patient was able to get up with assistance of a family member and was able to ambulate after the fall.During er examination the caregiver reported that patient seemed more confused after the fall, but denied loss of consciousness, nausea, vomiting or seizure-like activity.X-ray of the right elbow revealed evidence of a closed fracture of distal end of the right humerus with joint effusion of the right elbow.Cervical spine ct was without any findings.Head ct confirmed a small acute subarachnoid hemorrhage.Neurosurgery recommended no interventions.Orthopedic surgery recommended non-operative management of the humerus fracture.Patient got an elastic bandage with ortho-glass and cotton padding.The pain was controlled with iv medications, which were later transitioned to oral medications.Patient was discharged home on april 26, 2023.The patient's spouse mentioned to the health care provider, that the patient is using a rollator to carry the optune device, as it had been too heavy for the patient, but he gets up without the rollator frequently.The prescribing physician did not provide a causality assessment on this event.

Manufacturer Narrative

On june 8, 2023, additional information was discovered during review of an available medical record.During a neuro-oncology follow up visit on (b)(6) 2023, the physician noted due to increased confusion, the patient had a risk of falling as he forgot his walker and could be pulled off balance by optune.Novocure received additional information on may 29, 2023, that the patient had a hard time carrying the device due to the fracture of his dominant right arm.Optune therapy was discontinued on (b)(6) 2023.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 16945087
• MDR Text Key: 315362633
• Report Number: 3010457505-2023-00236
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2019
• 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: ACETAMINOPHEN; AMLODIPINE; BETA-CAROTENE A; BEVACIZUMAB; LEVETIRACETAM; METOPROLOL; MULTIVITAMIN TABS; ONDANSETRON; OXYCODONE; PROCHLORPERAZINE; SIMVASTATIN; SULFAMETHOXAZOLE- TRIMETHOPRIM; TEMOZOLOMIDE; VITAMINS C, E
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male