Model Number RNS-300M-K - FGI, PMA, RNS NEUROSTIMULATOR |
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 09/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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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 2 years.The rns was explanted on (b)(6) 2016 and returned to neuropace for analysis.Neuropace is currently investigating the returned device.The patient received a replacement device on (b)(6) 2016.
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Manufacturer Narrative
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(b)(4).No fault found.Upon receipt the device responded correctly to telemetry and the reported battery voltage was consistent with what was measured once the device was opened.The current drain in each of the 6 programmed settings that were used during implant was measured on the bench.The results matched expected results for a well-functioning device.An estimate of the battery capacity spent was made based on the diagnostic data available from the device.The diagnostic data is necessarily incomplete due to memory limitations of the implant so the result is a very rough estimate.The results were not conclusive but were consistent with a high detection rate resulting in a heavy therapy load causing the observed battery depletion.The implant battery was returned to the manufacturer, (b)(4), for destructive analysis.(b)(4) conducted a thorough investigation and found no anomalies.The most probable cause for this battery depletion is the high therapy load caused by a high detection rate.
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Event Description
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New information provided in investigation of returned device completed.
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Search Alerts/Recalls
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