Model Number 304-20 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problem
Pain (1994)
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Event Date 09/09/2014 |
Event Type
Injury
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Event Description
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It was reported that the vns patient was experiencing painful stimulation.The patient¿s device was subsequently disabled and the patient was referred for surgery.The patient¿s physician was suspecting a potential issue with the lead.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 an office visit on (b)(6) 2014, the vns patient complained of having shocking sensations in her neck along with dysphagia and muscle spasms.The patient had temporarily disabled her device with her magnet and the physician programmed the device off during the office visit.During an office visit on (b)(6) 2014, the patient¿s device was programmed back on and the patient subsequently had a nose bleed and coughing with stimulation.The patient¿s device was tested and showed normal device function at the time.The patient¿s device was again disabled for comfort.No patient trauma or programming changes preceded the onset of the patient¿s issues.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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Follow-up report #1 inadvertently did not include that the patient also experienced difficulty speaking during clinic visit on (b)(6) 2014.
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Manufacturer Narrative
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Event description, corrected data: follow-up report #1 inadvertently did not include patient's difficulty speaking during clinic visit on (b)(6) 2014.
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Event Description
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Information was received that the patient underwent full revision of the generator and lead on (b)(6) 2015.The explanted products were reported to be discarded and could not be returned to manufacturer.
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Search Alerts/Recalls
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