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Model Number 8103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Depression (2361); Unspecified Mental, Emotional or Behavioural Problem (4430)
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Event Date 10/29/2022 |
Event Type
Injury
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Event Description
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It was noted that study patient was admitted to a psychiatric hospital as an emergency case.No further information is available.Actions taken include studying device, change in medication, change in ect, change in tms, change in psychotherapy, surgery, diagnostic exams/tests, observation, and other.The outcome is unknown.The relationship to the device is unknown.No other relevant information has been received to date.
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Manufacturer Narrative
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Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
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Event Description
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Information was provided that the patient's adverse event is severe depression with psychotic features.
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Event Description
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It was reported that the severe depression with psychotic features is considered resolved.No other relevant information has been received to date.
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Search Alerts/Recalls
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