Model Number 106 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problems
Seizures (2063); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/24/2017 |
Event Type
malfunction
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Event Description
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The nurse reported that the patient's generator had 100% battery and then multiple months later, the battery was at 25%.The nurse believed that the battery depleted too quickly.The nurse also questioned whether or not two hospitalizations for the patient could have been caused by some sort of "surge" with the vns device.A review of the device history record for the generator revealed that the generator passed all functional and electrical requirements prior to release for distribution.No additional relevant information has been received to date.
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Event Description
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Further information was received from the nurse stating there was no surge believed to have occurred.Settings and diagnostics were sent in regarding the alleged premature battery depletion.
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Manufacturer Narrative
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Information that the patient's mother had reported an increase in seizures was inadvertently left off the supplemental mdr #1 report.Report source, corrected information: the "consumer" box should have been checked as the patient's mother was the reporter of the increase in seizures.Event problem codes, corrected information: code (b)(4) was inadvertently left off supplemental mdr #1 report as there was a report of an increase in seizures for the patient.
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Event Description
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Information was received from the patient's mother that the patient had a recent increase in seizures which she related to the battery depletion of the vns device.However it is known that the generator will provide programmed therapy until it reaches a pulse disabled state due to end of service and the last reported battery indicator was 25%.The patient was now pursuing a generator replacement.
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Manufacturer Narrative
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Date received by manufacturer, corrected date: in mfg report # 2, the date should have been (b)(6) 2017.
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Event Description
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It was reported via clinic notes that the patient's mother felt that the vns magnet was not working as well as before.It also stated that the patient would see the surgeon in anticipation of needing a replacement.A review of the programming data was performed however the premature battery depletion could not be observed with the available information.
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Event Description
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Additional programming data was received and reviewed for the patient.Diagnostics for the patients device were ok however the review of the programming data revealed that the device possibly depleted prematurely.
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Event Description
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Additional information was received that the patient's generator was replaced prophylactically.The explanted generator has not been received by the manufacturer to date.
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Search Alerts/Recalls
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