Clinic notes were received reporting that the patient feels like their battery is misplaced and that it is poking through her skin.The patient also feels painful stimulation in their chest.The physician attempted to interrogate the device multiple times, but was unsuccessful.The patient was referred to their surgeon and also complained of shocking sensations and tingling running along their left arm and neck; the patient suspects the vns generator may have moved and is causing the symptoms.The surgeon suspected that due to inability to interrogate the vns and onset of symptoms, a battery replacement would be needed.Response was received from the physician.Per the physician, the cause of the shocking and tingling sensations cannot be determined as the device cannot be interrogated.It was noted that the programming system has been used for other patient's with no difficulty.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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F10 health effect, clinical code: code e2402 utilized; appropriate term ¿protrusion¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.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.Health effect - clinical code :e2311.Health effect - clinical code :e1623.Health effect - clinical code :e233001.
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