LIVANOVA USA INC. VAGUS NERVE STIMULATOR (VNS); STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
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Model Number 57996 |
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Event Description
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Patient called about a vagus nerve stimulator from livanova model 57996.She had one and it died and she started having symptoms again.The battery was so dead they couldn't get any readings.Patient doesn't do well on the medicine.The device is to stop seizures.Patient said she had them both replaced within a two week period.She needs the therapy turned on.Redirected her to livanova."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".Ref report: mw5153523.
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