MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the wound infection is not related to optune therapy but related to post-operative craniotomy infection.Contributing factors for wound infection in this patient include: prior radiation, chemotherapy, underlying cancer, and prior surgeries affecting skin integrity.Wound infection 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 (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

A 66-year old female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2021.On (b)(6) 2022.Novocure was informed about the following case by the patient and on (b)(6) 2022.Treating physician provided additional details.On (b)(6) 2022.Cranial mri showed progressive liquid accumulation below (epi- vs.Subdural) the cranial bone flap and progressive perifocal edema, indicating infection with encephalitis or tumor recurrence.Tumorboard held (b)(6)2022.Suspected infection and recommended surgical revision.Patient was scheduled to outpatient presentation on (b)(6) 2022.The patient presented with clinical presentation of deterioration of speech and handwriting to the oncology consultation, the wound was irritation free.Patient was admitted on (b)(6) 2022.For revision surgery due to suspected chronic post-craniotomy infection left parietal (last craniotomy (b)(6) 2021).On (b)(6) 2022.The patient underwent wound revision surgery with removal of the bone flap.Intraoperative specimen collection showed contamination with staphylococcus capitis.Histology results showed, chronic inflammatory infiltrate, without tumor cells.Bone flap biopsy showed no evidence of osteolysis.Tthe patient was started on intravenous vancomycin from (b)(6) 2022.After inflammatory parameters declined, the patient received clindamycin.After developing exanthema, the patient received doxycycline from (b)(6) 2022.The patient's wound remained dry and irritation free.On (b)(6) 2022.The patient was discharged home on doxycycline.On (b)(6) 2022.During a follow-up appointment, the patient reported that she had to interrupt the antibiotic therapy due to an allergic reaction.The clinical and neurological findings show an improvement in motor aphasia as well as significantly decreased edema and fluid collection in the area of the dura.The wound appeared dry and irritation-free.On (b)(6) 2022.Patient resumed optune therapy after a two-month break.The patient's treating physician assessed that a relation to optune therapy could not be excluded.

• 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: 15382134
• MDR Text Key: 299507080
• Report Number: 3010457505-2022-00216
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• 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: TFH9100EU
• Device Lot Number: N/A
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2017
• 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: LEVETIRACETAM; LEVOCETIRIZINE; LEVOTHYROXINE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female