Model Number TFH9100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Headache (1880)
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Event Date 04/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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Novocure medical opinion is that a contribution of device use to the event cannot be ruled out.Migraine was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (1%) only.Headache is a common symptom of disease in gbm.
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Event Description
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Patient is a (b)(6) male with newly diagnosed glioblastoma who began optune therapy on (b)(6) 2018.On (b)(6) 2018, the patient reported that the heat generated by the device was causing migraines, leading to hospitalization.The prescribing physician was contacted for additional information with no response.
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Manufacturer Narrative
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On (b)(6) 2021, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4-suspect medical device model number.Corrected model number is tfh9100.
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Search Alerts/Recalls
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