MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Other contributing factors for wound complication 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

Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2016.At start of optune therapy, the patient was noted to have an open area along the surgical resection scar (resection performed (b)(6) 2015).Arrays were placed to avoid this area.On (b)(6) 2016 novocure was informed that the patient had an open area along the resection scar line had gradually become larger with some drainage.On (b)(6) 2016, patient reported scalp irritation and pain to the prescriber.A small pin hole sized wound was noted at the incision site, which was draining.Prescriber advised patient to temporarily discontinue optune therapy.On (b)(6) 2015, novocure was informed by the prescribing physician that on (b)(6) 2016, patient had been admitted to the hospital for planned wound debridement.The old hardware and bone flap were removed and replaced with new hardware.Cultures of the site did grow gram positive rods.On (b)(6) 2016 the patient was discharged home with a picc (peripherally inserted central catheter) line in place and prescribed a two week course of intravenous antibiotics.Patient planned to restart optune therapy once the wound was healed.The prescribing physician stated that the optune transducer arrays could have caused some additional irritation which may have led to the drainage even though the patient took care to avoid the affected areas when placing the arrays.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5634382
• MDR Text Key: 44503693
• Report Number: 3009453079-2016-00069
• 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: Patient
• Type of Report: Initial
• Report Date: 05/05/2016

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: TFH-9000
• 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: 10 MO
• Event Location: Home
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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: LAMOTRIGINE
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 76