MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9000

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

Patient Problem Convulsion, Clonic (2222)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Pt with glioblastoma (gbm) began optune treatment on (b)(6) 2014.On (b)(6) 2014, novocure was informed that the pt had recently been hospitalized due to seizure.Per hosp summary, pt was hospitalized on (b)(6) 2014 following onset seizure.At the time of the event, pt was in the process of dose escalation of anti-seizure prophylaxis (levetiracetam) to therapeutic dose level.Levetiracetam dose had recently been increased from 500 to 1000 mg.Dose was increased to 1500 mg at hosp.Levetiracetam blood values were not measured prior to or after the event.Brain ct showed evolving encephalomalacia in the area of the right frontal tumor resection.No acute hemorrhage, midline shift, hydrocephalus or acute ischemic changes were identified.Chest x-ray showed known pulmonary venous hypertension with no focal consolidation, pneumothorax or pleural effusion.On (b)(6) 2014, pt was discharged home in improved condition.Pt continued with optune therapy with no further seizure activity reported.Per physician at the prescribing site, the seizure was related to underlying gbm and was not related to optune.

Manufacturer Narrative

(b)(6) 2013: pt with glioblastoma experienced new onset seizure requiring hospitalization while on optune therapy.Novocure agrees with prescribing site physician that the seizure was related to underlying gbm.Seizure was not related to optune.Pt continued with optune therapy with no further seizure activity reported.Seizures were reported as adverse events on the pivotal phase iii recurrent gbm trial in both arms of the trial (9% and 4% in optune and chemotherapy arms respectively).None of these seizures were considered device of chemotherapy related by investigators.Seizures are a known complication of the underlying disease (recurrent gbm).Add'l risk factors for seizure in this pt include concomitant thalidomide (carries a warning to closely monitor pts with risk for the development of seizures closely for clinical changes that could precipitate acute seizure activity.Source: thalidomide prescribing info) and concomitant temozolomide adverse reactions in pts on temozolomide.Source: temozolomide prescribing info).

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg, sha'ar hacarmel; 4th fl; haifa 31905 ; IS 31905 ; 48501204
• MDR Report Key: 4381095
• MDR Text Key: 5240579
• Report Number: 3009453079-2014-00045
• 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: 12/02/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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: 47 YR