Model Number 103 |
Device Problems
Loss of Power (1475); Self-Activation or Keying (1557)
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Patient Problem
Vomiting (2144)
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Event Date 02/23/2016 |
Event Type
Injury
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Event Description
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It was reported that a vns patient had her device switched off for a while due to lack of efficacy.When the device was switched back on, by ramping up the output current from 0.25ma to 0.5ma, the patient vomited.The other device parameters were: pulse width 250 c, signal frequency 20hz, on time 0.7 sec and off time 0.8 min.A company representative suggested to the nurse to drop the pulse width from 250 c to 130 c.The nurse agreed to try that when the patient will be seen again in the clinic.Attempts to obtain additional information were unsuccessful to date.
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Manufacturer Narrative
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Corrected data: the previously submitted mdr inadvertently provided an incorrect patient information.
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Event Description
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Further information was received from a nurse, indicating that the event occurred on (b)(6) 2016.It was reported that the device settings were changed back down after the patient vomited; the output current was programmed to 0.25ma.The device was tested and system diagnostics returned impedance results within normal limits with 2602 ohms.It was reported that the patient's device was initially switched off on (b)(6) 2015, because there were no change to the patient's cluster seizures and it was felt that vns was causing breathlessness during sport.The patient asked to switch the device off for 3 months.After that period, the patient was happy to keep it switched off.It was reported that the patient's device was switched back on, on (b)(6) 2016 because the patient's seizures had started to increase.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.No additional information was provided to date.
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Event Description
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Additional information was provided indicating that the patient was continuing to have problems with vomiting and coughing with stimulation.The patient's settings had been lowered.When the patient was seen for a follow-up visit a few weeks later, the patient's physician opted to slowly program the patient's settings back up.
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Search Alerts/Recalls
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