MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9000

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Ulcer (2274)

Event Date 01/12/2015

Event Type  Injury  

Event Description

Pt with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2014.On (b)(6) 2014, pt experienced a non-serious scalp wound with associated infection which was treated with oral and topical antibiotics.On (b)(6) 2015, novocure was informed that the pt had been hospitalized.Per hospital summary provided by the prescriber, pt presented to the emergency department on (b)(6) 2015 with clear drainage from a left-sided scalp ulceration and a headache that was positional in nature, worse when laying flat.Pt denied any vision changes, fevers or chills.At the time of the event, pt was undergoing radiation therapy and was on concomitant temozolomide.Ct scan did not demonstrate any changes from previous.Neurosurgery was consulted and pt was admitted to neurosurgical icu.On (b)(6) 2015, pt experienced a seizure.Pt was treated with lorazepam and levetiracetam was continued with no seizure recurrence.Plastic surgery was consulted from possible craniotomy revision.On (b)(6) 2015, a lumbar drain was placed which improved csf output.Pt's condition improved.Pt's prognosis was considered to be poor and further surgery was not an option.On (b)(6) 2015, lumbar drain was removed with cessation of csf leak.On (b)(6) 2015, pt was discharged to home hospice in neurologically stable condition.

Manufacturer Narrative

Prescribing physician attributed the cause of the initial non-serious scalp wound to optune therapy.Novocure medical assessment is that optune therapy may have contributed to the subsequent skin ulcer.Other contributing factors for skin ulcer include: concomitant bevacizumab (vascular endothelial growth factor inhibitor which carries a black box warning for surgery and wound healing complications including wound dehiscence.Source: bevacizumab prescribing info), concurrent radiation, chemotherapy and prior surgery affecting skin integrity.Skin reaction and skin ulcer are known adverse events with use of optune therapy with an incidence of 16% for device site reactions and 1% for skin ulcer reported in the pivotal phase iii clinical trial in pts with recurrent gbm.There was 1 report of csf leakage in the optune arm of the pivotal ef-11 recurrent gbm trial.

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg., sha'ar hacarmel; 4th floor; haifa ; IS ; 48501204
• MDR Report Key: 4514734
• MDR Text Key: 5489216
• Report Number: 3009453079-2015-00049
• 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
• Report Date: 01/29/2015

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
• Other Device ID Number: 07290107980401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 73