Model Number 3772 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient was experiencing heating at the ipg site while recharging their device.As a result, surgical intervention took place on (b)(6) 2019 wherein the patient had their ipg explanted.
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Manufacturer Narrative
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As received, reported event for patient feels burns while charging was not confirmed.The ipg, after being depleted, was able to fully charge and pass auto test.Pocket heating testing while charging was conducted using the returned ipg and le charger for 10 hours using test method 76-0011 and analyses of the test data revealed that the temperature distributions on the ipg surface were within specification as indicated in compliance in the eon mini product requirements specification.No anomaly was observed that would have affected the operation of the ipg or reported event.
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Manufacturer Narrative
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As received, reported events of "patient feels burns while charging" and "patient feels significant heat at the implantation site of his neurostimulator, outside the recharge time" were not confirmed.The ipg, after being depleted, was able to fully charge and pass auto test.Pocket heating testing while charging, as well as while the ipg was providing stimulation, was conducted using the returned ipg and le charger for 10 hours using test method (b)(4) and analyses of the test data revealed that the temperature distributions on the ipg surface were within specification as indicated in compliance in the eon mini product requirements specification.No anomaly was observed that would have affected the operation of the ipg or reported event.
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Event Description
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It was reported that the patient was experiencing heating at the ipg site while charging and outside of the recharge time.
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Search Alerts/Recalls
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