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 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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It was reported that the patient has been vomiting everyday.Additional information was received noting that the adverse events of vomiting started after a battery replacement on.It was also noted that the patient underwent bile cleanout, prescribed medication, and was admitted to the hospital.It was noted that the patient settings were reduced to due to this.As the patient was interrogated and settings lowered, the diagnostics are automatically performed on the suspect product in which can be assumed to be within normal limits as any abnormal impedances would be reported during the settings change no other relevant information has been received to date.
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