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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 09/07/2015
Event Type  Injury  
Manufacturer Narrative
Novocure agrees with the prescribing physician that the seizure was related to underlying gbm.Seizure was not related to optune.Patient continued with optune therapy with no further seizure activity reported.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 (gbm).
 
Event Description
Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015, novocure was informed that on approximately (b)(6) 2015, the patient had been hospitalized due to new onset seizure.The patient was unsure of what happened prior to admission and "woke up" after a few days in the hospital.Optune was temporarily discontinued upon admission.The patient was started on unspecified anti-seizure medication.No further details on the hospitalization were available.Patient improved with no further seizure activity.Patient was discharged approximately two weeks later and resumed optune therapy.Prescribing physician stated that the event was caused by edema from pseudo-progression and was unrelated 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, 31905
IS  31905
Manufacturer (Section G)
NOVOCURE LTD.
topaz building, sha'ar
hacarmel 4th floor
haifa, 31905
IS   31905
Manufacturer Contact
eilon kirson
topaz building, sha'ar
hacarmel 4th floor
haifa, is 31905
IS   31905
48501204
MDR Report Key5159112
MDR Text Key28584812
Report Number3009453079-2015-00061
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
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 Expiration Date07/09/2014
Device Model NumberTFH-9000
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Device Age1 YR
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2014
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
BLOOD PRESSURE MED (UNKNOWN)
Patient Outcome(s) Hospitalization;
Patient Age54 YR
Patient Weight77
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