Information was received on from the patient¿s mother that she believed the surgeon did extensive nerve damage when implanting the device back as the patient could not feel anything from her chin to the middle of her incision for 6 months post-surgery.She notes the surgeon denied this, as did the patient¿s following neurologist, but the mother mentioned that the patient¿s primary care doctor believes that the patient did have nerve damage based on her symptoms.Regarding the numbness, the physician noted that the cause is unknown.A transverse cervical injury may contribute ( due to scarring from (illegible) tracheostomy but this alone will not explain symptoms patient has no intervention planned only observation.No additional clarifying information has been received to date.
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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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