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 12/13/2014

Event Type  Injury  

Event Description

Pt with recurrent glioblastoma (gmb) began optune treatment on (b)(6) 2014.On (b)(6) 2014, novocure was informed that the pt had visited the emergency room after experiencing a new onset seizure.Per the prescribing physician, the pt did not have a history of seizure and was not on anti-seizure prophylaxis prior to the event.Pt was admitted to the hospital and treated with unspecified anti-epileptics.Imaging results were not provided.Optune therapy was continued.Per the prescriber, the event was related to underlying gbm progression and involvement of the temporal lobe.The event was not related to optune therapy.

Manufacturer Narrative

Pt with glioblastoma experienced new onset seizure requiring hospitalization while on optune therapy.Novocure agrees with the 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 percent and 4 percent in optune therapy and chemotherapy arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of the underlying disease (recurrent gbm).Additional risk factors for seizure in this pt include concomitant bevacizumab [seizure was among the mose common bevacizumab-related toxicities in phase ii-iii studies, affecting 9-9.7 percent of pts.Source: lai et al., jco, 2011, 29 (2): 142-148 / chinot et al., neuro-onc, 2012, 14 (suppl 6): vi101-105] and concomitant temozolomide [convulsions are among the most commonly reported adverse reactions in pts on temozolomide.Source: temozolomide prescribing information].

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bulidng , sha'ar hacarmel; 4th floor; haifa 31905 ; IS 31905 ; 4850124
• MDR Report Key: 4417624
• MDR Text Key: 5372748
• Report Number: 3009453079-2015-00046
• 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: 12/13/2014

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?: No
• Initial Date Manufacturer Received: 12/13/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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: POLYETHYLENE GLYCOL; DOCUSATE SODIUM; ACETAMINOPHEN; LORAZEPAM; TRIMETHOPRIM/SULFAMETHOXAZOLE; ETOPOSIDE; BEVACIZUMAB; ONDANSETRON; CARBOPLATIN
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR
• Patient Weight: 28