MAUDE Adverse Event Report: NOVOCURE LTD LOPTUNE

Model Number TFH-9000

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

Patient Problem Convulsion, Tonic (2223)

Event Date 01/30/2015

Event Type  Injury  

Event Description

Pt with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015, novocure was informed that the pt has been hospitalized in the intensive care unit (icu) following a new onset seizure.On (b)(6) 2015, pt developed left upper extremity twitching of 2 hour duration which progressed to a diffuse tonic-clonic seizure with obtundation.Pt was transported to the emergency room via ems.In the er, pt was noted to be without spontaneous respirations and was bagged.Wife requested that pt's dnr order be revoked so pt could be intubated, which was done.Pt was first treated with iv levetiracetam and then later treated with dexamethasone.Brain ct scan showed a large mass in the right parietal-occipital lobe extending into the temporal lobes.There was also a moderate amount of vasogenic edema surrounding the tumor.Brain mri done 2 days prior to admission had shown gbm progression with increased enhancement and edema in several areas of the brain.Portable chest x-ray showed low lung volume with bibasilar atelectasis.On january 29, (b)(6) care.On (b)(6) 2015, pt was discharged to hospice.Optune therapy was permanently discontinued upon hospice admission.Per the prescribing physician, the pt did not have a history of seizure and was not on anti-seizure prophylaxis prior to the event.The prescribing physician stated that the seizure was related to gbm progression and was not related to optune therapy.

Manufacturer Narrative

Mfg date: 03/01/2013.Novocure agrees with the prescribing physician that the seizure was related to underlying gbm.Seizure was not related to optune therapy.Seizures were reported as adverse events on the pivotal phase iii recurrent gbm trial in both arms of the trial ((b)(4)).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of underlying disease (recurrent gbm).Add'l risk factors for seizure in this pt include concomitant bevacizumab [seizure was among the most common bevacizumab-related toxicities in phase ii-iii studies, affecting 9-9.7% of pts.Source: lai et al., jco, 2011, 29(2): 142-148 / chinot et al., neuro-onc, 2012, 14 (supple 6): vi101-105] and concomitant temozolomide [convulsion are among the most commonly reported adverse reactions in pts on temozolomide.Source: temozolomide prescribing information].

• Brand Name: LOPTUNE
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg. , sha'ar hacarmel; 4th floor; haifa ; IS ; 48501204
• MDR Report Key: 4543889
• MDR Text Key: 19353787
• Report Number: 3009453079-2015-00050
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/04/2015

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?: No
• Initial Date Manufacturer Received: 02/14/2015
• Initial Date FDA Received: 02/24/2015
• 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
• Treatment: ANDANSETRON; SERTRALINE HCL; PANTOPRAZOLE; BISACODYL; ATORVASTATIN; METHYLPHENIDATE; DEXAMETHASONE; AMLODIPINE; ZALEPLON; BEVACIZUMAB; TEMOZOLOMIDE; ALPRAZOLAM; ACETAMINOPHEN; ENOXAPARIN SODIUM; METROPROLOL
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR