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 10/19/2022

Event Type  Injury  

Event Description

A 65-year old male patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.On (b)(6) 2022, the patient discontinued optune therapy.On (b)(6) 2022, patient noticed secretion from the surgical wound, was feverish, and experienced worsened hemiparesis.On (b)(6) 2022, the patient went to the hospital following a fall.The patient presented with putrid secretion from a punctiform lesion near the surgical resection incision (last surgical resection (b)(6) 2022).The incision did not appear irritated.The patient was admitted due to a suspicion of a wound healing disorder.On (b)(6) 2022, patient underwent wound revision surgery with removal of right frontal bone flap and washout of subdural empyema followed by duraplasty and re-insertion of the bone flap.Status-post, the patient showed a distinct reduction of vigilance prompting a cranial ct which showed an acute right subdural hematoma.An emergent craniotomy was performed to remove the hematoma, without any complications.The patient was administered intravenous antibiotics with improvement.On (b)(6) 2022, after removal of drainage, the patient's vigilance declined and a repeat cranial ct demonstrated residual subdural hematoma.The patient underwent a second right frontal craniotomy to remove the remaining hematoma, without complications.Microbiology confirmed staphylococcus aureus and enterobacter cloacae complex.Antibiotic therapy (vancomycin and meropenem) administered which resulted in a decline of inflammation parameters.On (b)(6) 2022, patient was discharged home in reduced general condition with palliative care.The wound appeared dry and not irritated at the time of discharge.The prescribing physician did not provide a causality assessment as the patient was not in his care at the time of the event.

Manufacturer Narrative

(b)(6) medical opinion is that the contribution of the array placement to the wound infection cannot be ruled out.Contributing factors for wound infection in this patient include: prior chemotherapy, concomitant dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease, 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).

• 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: 15801157
• MDR Text Key: 303700998
• Report Number: 3010457505-2022-00218
• 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: 11/15/2022

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: TFH9100EU
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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; ENOXAPARIN SODIUM; LEVETIRACETAM; LEVOTHYROXINE; METAMIZOLE; OXYCODONE; PANTOPRAZOLE; TAMSULOXIN HYDROCHLORIDE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male