MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Headache (1880)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of device use to the headache cannot be ruled out.Headaches were reported on 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 (28% and 20% in optune/tmz and tmz arms respectively).Headache is also a common symptom of disease in gbm.

Event Description

A (b)(6) male with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2018.On (b)(6) 2018, patient was hospitalized with severe head pain while using optune.Optune was discontinued upon admission.At the time of the report, prescribing physician assessed the headache as related to optune therapy.Ct scan showed no gross evidence of acute pathology or significant change since previous scan.Mri showed mild edema with no progression.Patient was continued on dexamethasone and started on fentanyl for the headache.Patient was discharged on (b)(6) 2018.On (b)(6) 2018, patient was readmitted to the hospital with continued headache as well as delirium, dysphagia, hiccups and immobility.Patient was found to be over sedated with fentanyl.Dexamethasone and fentanyl were discontinued and patient was started on methylprednisolone and hydromorphone.Headache was assessed as secondary to intracranial disease per hospital discharge summary.Patient was discharged (b)(6) 2018 in improved condition.Per the prescribing physician, the cause of the headache was uncertain but the patient was cleared to resume optune therapy.On (b)(6) 2018, the patient's spouse reported that the patient had tried to resume optune therapy but after about 3 hours, his headache started again and he went back to the hospital.There was no report of hospital admission or treatment for the event.No further information was provided.On july 19, 2018, novocure was informed that the patient had permanently discontinued optune therapy.

Manufacturer Narrative

On august 23, 2022, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4: suspect medical device model number.Corrected model number is tfh9100.

• 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; hacarmel 4th floor; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 7722302
• MDR Text Key: 115103327
• Report Number: 3009453079-2018-00105
• 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: 09/16/2022

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
• Is the Reporter a Health Professional?: No
• Device Age: 2 YR
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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; FLUCONAZOLE; FLUOXETINE; HYDROMORPHONE; LACOSAMIDE; LACTULOSE; LORAZEPAM; METAXALONE; METHYLPREDNISOLONE; ONDANSETRON; PANTOPRAZOLE; PROCHLORPERAZINE; TEMOZOLOMIDE; WARFARIN; DEXAMETHASONE; FLUCONAZOLE; FLUOXETINE; HYDROMORPHONE; LACOSAMIDE; LACTULOSE; LORAZEPAM; METAXALONE; METHYLPREDNISOLONE; ONDANSETRON; PANTOPRAZOLE; PROCHLORPERAZINE; TEMOZOLOMIDE; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 69 KG