MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Abscess (1690); Post Operative Wound Infection (2446)

Event Date 09/22/2019

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician that a contribution of the array placement to the event cannot be ruled out.Contributing factors for wound infection in this patient also include, prior radiation, chemotherapy, and prior surgery affecting skin integrity.Wound infection and abscess are expected events with device use and were reported as adverse events 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 (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

A (b)(6) year old male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019.On (b)(6) 2019, prescribing physician reported that the patient had experienced scalp swelling around the transducer arrays.Patient visited the emergency department and optune therapy was discontinued.The patient was not admitted.On (b)(6) 2019, the patient's caregiver provided additional information regarding the event.The reporter stated that in addition to the scalp swelling, the patient had experienced swelling of one side of his face and his eye.On (b)(6) 2019, novocure was informed by the prescriber that the patient had experienced a new area of swelling at the same location on the scalp and had returned to the emergency department.Patient was admitted for a wound clean out followed by an antibiotic infusion.Blood cultures were (b)(6).On (b)(6) 2019, prescriber stated that patient required a second wound clean out due to a newly formed abscess at the same area on the scalp.On (b)(6) 2019, novocure received additional information from the neurosurgeon.According to the neurosurgeon, at the start of surgery, the abscess popped open and pus drained from the area.The area was cleaned.The neurosurgeon explored through the dura for any signs of infection inside the skull and determined the infection was superficial.A small flap was placed in the dura hole and the area was sutured.Prescriber stated that he could not rule out that optune therapy may have contributed to the event.

Manufacturer Narrative

On (b)(6) 2019, novocure received additional information from the neurosurgeon stating that the wound infection may have been caused from a cut from the shaver when the patient shaved the scalp in preparation to begin optune therapy on (b)(6) 2019.No additional information received.Novocure agrees with the neurosurgeon that a contribution of array placement to the event cannot be ruled out.

Manufacturer Narrative

On november 08, 2019, novocure received additional information from the prescribing physician.Per clinic notes, within 12 hours of starting optune, the patient reported itching and swelling in the skin over the right eye.Due to these symptoms he presented to the ed.He was treated with steroids and diphenhydramine and over several days the patient's symptoms resolved.The prescriber deemed that this was an allergic reaction to adhesive in the optune bandage and the patient discontinued optune use.Approximately two weeks after first starting optune, the swelling had come back and was also red and warm.The patient was sent back to the ed for evaluation.Patient was deemed to have an infection in the soft tissue of the scalp.Mri of the brain on (b)(6) 2019 showed a subcutaneous abscess.On (b)(6) 2019, repeat brain mri showed that the abscess had resolved.On (b)(6) 2019, patient was seen in the clinic and reported continued headaches.Chemotherapy was being held until the surgical wound healed.

Manufacturer Narrative

On december 23, 2021, 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, NH 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 9218039
• MDR Text Key: 167970292
• Report Number: 3009453079-2019-00122
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2022

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?: Yes
• Distributor Facility Aware Date: 09/23/2019
• Device Age: 3 YR
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 10/24/2019; 11/08/2019; 12/23/2021
• Supplement Dates FDA Received: 11/07/2019; 12/05/2019; 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2016
• 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: CLONAZEPAM; LEVETIRACETAM; ONDANSETRON; OXYCODONE; PAROXETINE; TEMOZOLOMIDE; ZOLPIDEM
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 71 KG