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, Tonic (2223)

Event Date 02/22/2015

Event Type  Injury  

Event Description

Pt with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2014.On (b)(6) 2015, novocure was informed that the pt had been hospitalized following a new onset seizure.Pt did not have a history of seizures and was not on anti-seizure medication.Pt was treated with dexamethasone and an unspecified anti-seizure medication.Imaging results were not provided.Optune therapy was continued.Per prescribing physician, cause of the seizure was underlying gbm.The event was not related to optune therapy.On (b)(6) 2015, novocure was informed that the pt had died on (b)(6) 2015.Prescribing physician stated the cause of death was progressive gbm and unrelated to optune therapy.

Manufacturer Narrative

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% and 4% 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).

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg, sha'ar hacarmel; 4th fl; haifa ; IS ; 4851204
• MDR Report Key: 4667423
• MDR Text Key: 5619680
• Report Number: 3009453079-2015-00053
• 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: Other
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/16/2015
• Initial Date FDA Received: 04/07/2015
• 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: ZOLPIDEM; ASPIRIN; POLYETHYLENE GLYCOL; OLMESARTAN; ACETAMINOPHEN; BACLOFEN; OXYCODONE; SENNOSIDES-DUCOSATE SODIUM; CITALOPRAM; DEXAMETHASONE; MELATONIN; SODIUM CHLORIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 67