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Model Number 102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Convulsion, Clonic (2222); Choking (2464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/29/2022 |
Event Type
Injury
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Event Description
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It was reported by fda medwatch report that; implanted medical device programmer was hacked.Symptoms included seizures, swelling, incontinence, nausea, choking, sleep disruption, vertigo, etc; patient information and m102 sn are not releasable.Mdr report # mw5112400.Reporter and managing physician information are not provided.No other relevant information has been received to date.
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Manufacturer Narrative
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(b)(4).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 livanovas 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.(b)(4).
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Search Alerts/Recalls
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