MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9000

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the treating physician that the event is not related to optune.Contributing factors for wound infection in this patient include prior radiation, chemotherapy and prior surgery affecting skin integrity.Postoperative wound infection was reported as an adverse event in the ef-14 pivotal 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%).

Event Description

Patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2016.On (b)(6) 2016, the patient was admitted from clinic after noting that a small part of her resection wound had a lump that was draining fluid.Optune therapy was discontinued upon admission.The patient elected to undergo a right cranial wound exploration and washout.Intraoperatively there were no findings of gross purulence; rather it appeared to be a small stitch abscess.Final diagnosis was postoperative superficial wound infection.The patient was treated with pain medications and started on a broad spectrum antibiotic, which was later replaced with a 10 day course of oral sulfamethoxazole/trimethoprim and amoxicillin/clavulanate.The patient was discharged home in stable condition on (b)(6) 2016.Patient planned to restart optune therapy upon completion of antibiotic course.Per the treating physician, the event was not related to optune.

Manufacturer Narrative

On august 23, 2022, 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 tfh9000.

• 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: 6060266
• MDR Text Key: 58501663
• Report Number: 3009453079-2016-00077
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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: TFH9000
• 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: 5 MO
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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: CYANOCOBALAMIN; FAMOTIDINE; FOLIC ACID; CYANOCOBALAMIN; FAMOTIDINE; FOLIC ACID
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG