Model Number RNS-300M-K - FGI, NS, RNS-300M-K |
Device Problem
Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Remains implanted.
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Event Description
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The rns reset to inactive mode when the battery reached end of life after being implanted for approximately 1.4 years.Ram code reinstallation was scheduled for (b)(6) 2016, the patient missed his appointment.The device is currently inactive.The patient has not rescheduled.He and his physicians know that the device is at end of life.
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Manufacturer Narrative
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(b)(4).On 10/19/2016 ram code was reinstalled in the neurostimulator device.The eos reset was cleared and the battery measurement was 2.73v, review of device sessions did not confirm device failure.On 11/3/2016 the rns reached eos and the device reset to inactive mode.On 1/4/2017 investigation completion: software and electrical engineering reviewed the device diagnostics.The analysis showed that the neurostimulator spent several programming epochs delivering high therapy loads so that a shortened battery life would be expected.Due to the partial nature of the available data it was not possible to determine exactly how much shorter than typical the battery life would be.A review of the battery discharge over time indicated a normal battery discharge.This analysis did not preclude the possibility that the device depleted prematurely.The device is currently inactive and remains implanted in the inactive mode.
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Search Alerts/Recalls
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