MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Contributing factors for wound dehiscence in this patient include prior radiation, chemotherapy, and prior surgery affecting skin integrity.Wound dehiscence 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 the optune/tmz arm of the trial (<1%) only.

Event Description

A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017.On (b)(6) 2018, novocure was informed by the prescribing physician that the patient had been hospitalized due to a skin tear and exposed hardware.Optune therapy was discontinued.Per medical history, the patient first reported non-serious skin lesions during a clinic visit on (b)(6) 2018 and was treated with neomycin/polymyxin/bacitracin ointment.On (b)(6) 2018, the patient experienced a recurrence of the event which resulted in a 12 day treatment break from optune therapy.On (b)(6) 2018 the patient resumed optune therapy and on (b)(6) 2018, the patient's scalp was described as improved.On (b)(6) 2018, the prescriber reported that the patient's prior skin ulcer, which had been superficial and healed, had developed into a wound with exposed surgical hardware.Patient was admitted to the hospital and underwent surgical repair.Intravenous antibiotics were given and the patient remained in stable condition.The patient was not on bevacizumab or steroids at the time of the event.The prescriber stated that optune therapy did contribute to the event.

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, 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: 7654339
• MDR Text Key: 112859402
• Report Number: 3009453079-2018-00104
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,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
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2016
• 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: ATORVASTATIN.; BUPROPION HCL.; CLOBETASOL PROPIONATE CREAM.; ONDANSETRON.; TEMOZOLOMIDE.; ATORVASTATIN; BUPROPION HCL; CLOBETASOL PROPIONATE CREAM; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female