Model Number 104 |
Device Problems
High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Undesired Nerve Stimulation (1980); Pain (1994); Neck Pain (2433)
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Event Date 06/19/2018 |
Event Type
Injury
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Event Description
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It was reported by the physician that the patient was experiencing painful stimulation in the neck where the electrodes were located.The patient's settings were subsequently turned down and the patient was referred for a full revision surgery.Diagnostics were not performed at the patient's appointment.The patient's device was subsequently disabled later in the day.It was later reported that the patient was also having erratic stimulation.No additional relevant information has been received to date.No surgical intervention has been known to have occurred to date.
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Event Description
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Information was received that the patient's generator was turned off.The patient's generator was tested and lead impedance was within normal limits.The physician thought that the patient's normal output was too high and not tolerable.The physician has restarted the vns therapy at the minimum dose and will gradually titrate up.
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Event Description
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Information was received that the patient was titrated to 0.5 ma, but couldn't tolerate stimulation as they were experiencing pain in the neck near the incision site.The patient has been referred for a full revision.No additional relevant information has been received to date.No surgical intervention is known to have occurred to date.
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Event Description
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Information was received that the patient is having throat pain due to an impedance issue.The patient's generator was turned off.
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Event Description
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Information was received that the patient did not have high impedance and device has not been interrogated since (b)(6) 2018.The patient's device was turned off due to pain no associated with stimulation and noted in the clinic notes as "per previous issues".No additional relevant information has been received to date.
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Search Alerts/Recalls
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