Model Number 102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Seizures (2063); Anxiety (2328); Neck Pain (2433)
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Event Date 05/01/2016 |
Event Type
malfunction
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Event Description
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It was reported that the patient started experiencing pain at the generator site recently.The pain was not reported to be associated with stimulation.The pain is however causing the patient to have panic attacks which lead to increased seizures.Patient was provided a neurologist contact information and asked to follow up with the physician regarding the concerns.However, no additional relevant information was received.
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Event Description
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Additional information was received that the patient is still having pain in his arms/legs and generator site, but this pain is present even when the device is "off." patient has held the magnet up to his generator for 5 minutes at a time t temporarily disable stimulation, and experiences worse pain during the disablement.The pain often wakes him from sleep and he wakes up in a sweat.Patient said that a doctor has mentioned that this could be related to anxiety, but it has not been confirmed.Additional information was received that the patient's vns settings were programmed at unusual setting of 30 seconds on time and 150 minute off time.The reason patient was feeling pain during the stimulation was because the settings were too high and there was a long break in between.The physician adjusted the patient's settings to a normal duty cycle and reduced the output current but the settings and diagnostics were not provided.Seizure patterns will be evaluated on an ongoing basis now that the vns has been programmed appropriately.
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Event Description
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Patient underwent explant surgery due to shoulder and neck pain.The physician stated that the patient demanded it be removed due to shoulder and neck pain.A portion of the lead was cut but the electrodes remain implanted.No other relevant information was received.
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Event Description
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Follow-up was later received that the patient will have the remaining portion of the lead removed.The additional surgery is not known to have occurred to-date.
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Event Description
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The additional surgery to remove the remaining portion of the lead occurred.
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Search Alerts/Recalls
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