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Model Number 300-20 |
Device Problems
Circuit Failure (1089); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/18/2013 |
Event Type
malfunction
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Event Description
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On (b)(6) 2013, it was reported that system diagnostics showed dcdc=0.Device settings were noted and there had been no change in seizures (still seizure-free); however, the patient was no longer feeling the stimulation since an unknown date.The patient¿s settings were increased, but the patient still could not feel the stimulation.Diagnostics were again performed, which showed dcdc=0 on system and dcdc=1 on normal mode.It was decided at that time that the patient would be referred for lead revision due to a suspected short circuit.Clinic notes dated (b)(6) 2013 were received.Diagnostics on this date showed unclear diagnostic results; however, it is believed that the results were within normal limits with neos: yes.Attempts will be made for additional information.No other information has been received to date.Surgery is likely, but has not occurred to date.
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Manufacturer Narrative
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Device manufacturing records and programming history were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Event Description
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On (b)(6) 2014, it was reported that following an increase in settings, the patient still could not feel stimulation in the neck but could now feel stimulation in the chest.Diagnostics showed dcdc=0, but there was no ¿limit¿ output status.On (b)(6) 2014, the patient underwent surgery.A battery and lead inspection reportedly showed a lead impedance issue.The lead and generator were explanted but not replaced at this time due to significant scarring around the jugular.Additional information was received stating that surgery was performed due to short circuit condition evidenced by dcdc=0 and clinical effect of stimulation in the chest.The surgery also involved repair of the side wall of the jugular vein and a general surgeon was called in to assist.It is unknown whether the injury occurred before or during surgery.X-rays have not been taken and the patient has not been re-implanted to date.Patient manipulation or trauma is not believed to have occurred.Attempts to have the product returned for analysis were made but have been unsuccessful to date.
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Search Alerts/Recalls
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