MAUDE Adverse Event Report: NOVOCURE, LTD NOVOTTF-100A

Model Number TFH-9000

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

Patient Problem Infarction, Cerebral (1771)

Event Date 05/20/2014

Event Type  Injury  

Event Description

On (b)(6), 2014 novocure was informed by the spouse that the patient had been hospitalized due to a stroke.Per hospital summary provided by prescribing site, on (b)(6), 2014 the patient noted left hand limited grip strength and left side limited strength.Patient also complained of slurred speech and difficulty getting dressed.On (b)(6), 2014, patient presented to hospital with worsened left hand grip strength, left sided weakness and difficulty swallowing.Novottf therapy was discontinued upon admission.Stroke work-up showed unremarkable computed tomographic angiography (cta), normal alc, normal transthoracic echocardiogram (tte) and slightly elevated ldl.Final diagnosis was acute right putamen/corona radiata ischemic infarct secondary to atherosclerosis exacerbated in the setting of prior radiation treatment.Aspirin was started on admission and will be continued.Statin therapy was held given ongoing glioma treatment.On (b)(6), 2014, patient was discharged to a rehabilitation facility.Patient planned to restart novotff therapy upon discharge home.

Manufacturer Narrative

Additional serial # (b)(4).Novocure concurs with the treating physician that the event was related to atherosclerosis exacerbated in the setting of prior radiation treatment.Event was not related to novottf therapy.Cerebral artery infarct was not reported in the pivotal phase iii recurrent gbm trail.In the commerical program, there has been 1 prior report of cerebral artery infarct, which was not related to novottf therapy, risk factors for stroke in this patient include: prior radiotherapy and multiple tumor resection surgeries, high cholesterol, obstructive sleep apnea and age.

• Brand Name: NOVOTTF-100A
• Manufacturer (Section D): NOVOCURE, LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg sha'ar hacarmel; 4th floor; haifa 31905 ; IS 31905 ; 48501204
• MDR Report Key: 3940210
• MDR Text Key: 4577693
• Report Number: 3009453079-2014-00040
• 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: 05/21/2014

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: Other
• Device Model Number: TFH-9000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ASCORBIC ACID; ACETAMINOPHEN; OXYBUTYNIN; PHENOBARBITAL; CHOLECALCIFEROL; ASPIRIN; MELATONIN; CITALOPRAM
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 54