Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
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Event Date 08/03/2015 |
Event Type
malfunction
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Event Description
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Clinic notes were received indicating that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015.It was noted that the patient's seizures were fairly controlled at that time.The patient returned to the office on (b)(6) 2015.The patient's mother indicated that the patient's seizures had gotten worse.The patient's medication was subsequently increased.The patient was referred for surgery but no known surgical interventions have occurred to date.
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Event Description
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Additional information was received stating that during generator and lead replacement surgery on (b)(4) 2015, the surgeon was unable to complete the procedure due to fibrosis around the electrode site and the patient's anatomy.The replacement generator was tested to the existing lead and diagnostic results continued to show a high impedance condition.The surgeon opened up the neck incision site but was unable to explant the lead electrodes from the patient's vagus nerve due to fibrosis.The surgeon noted that the patient's vagus nerve was "tangled and bundled with other nerves" above the electrode site and was unable to locate an implant location for the replacement lead.The patient's generator was explanted along with a portion the lead.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.The patient has not been re-implanted to date.
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Event Description
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Additional information was received stating that the patient was re-implanted on (b)(6) 2015.The generator and lead were placed on the right side of the patient's chest and vagus nerve.
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Search Alerts/Recalls
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