Model Number 105 |
Device Problem
Device Inoperable (1663)
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Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
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Event Date 10/20/2015 |
Event Type
malfunction
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Event Description
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It was reported that the patient's vns magnet mode is not thought to be functioning.It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015.The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort.No additional relevant information has been received to date.
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Event Description
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Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator.Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted.Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation.Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue.It was reported that there are no longer any suspected issues with the patient's generator.No additional relevant information has been received to date.
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Manufacturer Narrative
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Corrected data: this information was inadvertently left off of supplemental mfr.Report #01.Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation.Device diagnostics were within normal limits and device settings were reduced.The physician believes the patient is overly sensitive to device stimulation.The patient was reported to be fine after device settings were reduced." this information was inadvertently left off of supplemental mfr.Report #01.
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Event Description
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It was reported that the patient was experiencing shortness of breath with device stimulation.Device diagnostics were within normal limits and device settings were reduced.The physician believes the patient is overly sensitive to device stimulation.The patient was reported to be fine after device settings were reduced.It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion.The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months.The device was then programmed back on to a very low setting.The stimulation is now tolerable.The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.
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Event Description
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It was reported that vns was never efficacious per the mother.Per the mother, the seizures have never changed post-implant.No surgical intervention has occurred to date.No additional relevant information has been received to date.
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Event Description
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Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns).However, they had not seen the patient since 2014.The mother had mentioned wanting a mri and vns explant to the last treating physician's office.No surgical intervention has occurred to date.No additional relevant information has been received to date.
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Search Alerts/Recalls
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