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 10/18/2018

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 infection in this patient include underlying cancer disease and prior surgery 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 (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018.On (b)(6) 2018, the patient's spouse informed novocure he had observed a pus-like discharge from the patient's previous resection site in the right parietal region on (b)(6) 2018.The patient was brought to the hospital and underwent a surgical repair on (b)(6) 2018, with a bone flap removal.The origin of the wound infection was noted to be from the skin surface.No additional information was provided.Optune therapy was discontinued.The prescribing physician did not provide an assessment of the relationship of the event to optune therapy.

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: 8037034
• MDR Text Key: 126069187
• Report Number: 3009453079-2018-00110
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• 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?: No
• Device Age: 1 YR
• Initial Date Manufacturer Received: 10/20/2018
• Initial Date FDA Received: 11/05/2018
• 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: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LEVETIRACETAM; TEMOZOLOMIDE; LEVETIRACETAM; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: Asian