Model Number TFH9100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cognitive Changes (2551)
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Event Date 12/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Novocure medical opinion is that the mental status changes were related to underlying disease (gbm), disease progressions and brain edema and not related to optune therapy.Mental status changes were reported on the pivotal ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of trial (1% and 1% in optune/tmz and tmz arms respectively).Mental status changes are a common symptom of gbm.
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Event Description
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A (b)(6) male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2019.On (b)(6) 2020, the patient's son reported that the patient had been hospitalized.On (b)(6) 2020, the prescribing physician provided a hospital discharge summary including a radiation oncology note from (b)(6) 2019 which stated that the patient had been admitted to the hospital on (b)(6) 2019 with altered level of consciousness.Etiology was not clear.Head ct showed possible increased edema in the posterior corpus callosum.Patient did not receive steroids for the event.Patient was experiencing gbm progression.On (b)(6) 2020, the patient was transferred to a nursing home for rehabilitation and continued optune therapy.The treating radiation oncologist assessed the mental status changes as possibly related to optune.
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Manufacturer Narrative
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On december 23, 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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