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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

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NOVOCURE LTD. OPTUNE Back to Search Results
Model Number TFH-9000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 09/25/2015
Event Type  Injury  
Manufacturer Narrative
Novocure agrees with the prescribing physician that the seizures were related to underlying anaplastic astrocytoma.Seizures were not related to optune.Seizures were reported as adverse events in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (16% and 18% in optune/tmz and tmz arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of the underlying disease (anaplastic astrocytoma).
 
Event Description
Patient with newly diagnosed anaplastic astrocytoma began optune therapy on (b)(6), 2015.On (b)(6), 2015, novocure was informed that on (b)(6), 2015 the patient had been hospitalized due to new onset seizure.The patient had experienced three six minute seizures without return to baseline prior to presentation.Mri did not show any new areas of enhancement or increased perfusion signal, compared to previous (on (b)(6) 2015).Anti-seizure medication (levetiracetam) was increased however, the patient had two additional seizures on (b)(6), 2015.The patient was loaded with phenytoin but developed a drug reaction (itching) and was switched to lacosamide.The patient did not experience further seizures during the hospital stay but remained tired and significantly weaker than before the seizures.Weakness was attributed to seizures and steroid (dexamethasone) myopathy.Seizure precautions were continued during the hospital stay.At the time of the report, the patient was still hospitalized with plans to discharge home with occupational therapy and physical therapy for ongoing weakness.Per the prescribing physician, the seizures were related to disease progression and were not related to optune therapy.
 
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Brand Name
OPTUNE
Type of Device
OPTUNE
Manufacturer (Section D)
NOVOCURE LTD.
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS  31905
Manufacturer (Section G)
NOVOCURE LTD.
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS   31905
Manufacturer Contact
eilon kirson
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS   31905
48501204
MDR Report Key5205296
MDR Text Key30548726
Report Number3009453079-2015-00062
Device Sequence Number1
Product Code NZK
UDI-Device Identifier07290107980401
UDI-Public07290107980401
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/29/2015
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 NumberTFH-9000
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Device Age3 YR
Initial Date Manufacturer Received 10/09/2015
Initial Date FDA Received11/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ENOXAPARIN SODIUM
Patient Outcome(s) Hospitalization;
Patient Age56 YR
Patient Weight69
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