MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Ulcer (2274)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution to the event cannot be excluded.Contributing factors for skin ulcer in this patient include: prior radiation, chemotherapy, prior surgery affecting skin integrity.Skin ulcer 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) 2019.On (b)(6) 2019, novocure was informed by the prescribing site nurse that during a transducer array exchange on (b)(6) 2019, an open sore was observed on the scalp with exposed cranium hardware (last resection (b)(6) 2019).Prescribing physician instructed the patient to seek treatment at the emergency department for a possible infection associated with the ulceration.No further information on treatment and clinical course was provided.Prescribing physician was contacted for additional information and causality assessment with no response.

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: 9315046
• MDR Text Key: 166318755
• Report Number: 3009453079-2019-00127
• 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: Nurse
• 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
• Device Age: 3 YR
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/13/2019
• 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: 09/25/2016
• 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: CLOBETASOL; CLONAZEPAM; COMPAZINE; HYDROXYZINE; LACOSOMIDE; LEVITERACETAM; LEVOTHYROXINE; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 47 KG