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Model Number RNS-320-K |
Device Problems
Failure to Transmit Record (1521); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The explanted device was returned to neuropace and is undergoing analysis.
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Event Description
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The patient reported having issues interrogating the rns neurostimulator on (b)(6) 2019.Up until that date, the patient had not experienced any problems.The patient was provided with a new rns system remote monitor and wand; however the telemetry problem continued to persist.The patient was seen for an appointment on (b)(6) 2019, no telemetry was able to be established with the rns neurostimulator.Analysis of the most recent ecog files uploaded from the neurostimulator as of (b)(6) 2019 were analyzed, however the device was performing as expected and there was no evidence of a telemetry problem.The patient and caregiver denied any seizure-related trauma, medical procedures, or any other possible interactions occurring near the neurostimulator implant site between (b)(6).The treating center made several attempts to schedule the device replacement with the patient, however the patient was unable to attend until (b)(6) 2020.The rns neurostimulator was replaced on (b)(6) 2020 without complication.
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Manufacturer Narrative
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(b)(4).Telemetry with the rns neurostimulator was unable to be established; therefore the device was explanted and returned to neuropace for investigation.Analysis of available rns neurostimulator data on pdms showed no abnormalities.When received at neuropace, telemetry was still unable to be established with the device.Investigation identified low battery voltage and collapse of an internal supply component which is consistent with exposure to high energy [such as an electrosurgical unit (esu)].As previously reported, the patient and caregiver denied any seizure-related trauma, medical procedures, or any other possible interactions occurring near the neurostimulator implant site between july 17 and 18 which may have involved esu.Therefore, the cause of the telemetry issue remains undetermined.
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Event Description
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The explanted device was received by neuropace on 10 feb 2020 for investigation.
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Search Alerts/Recalls
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