Model Number RNS-320-K |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Erosion (1750)
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Event Date 09/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) the explanted product was not returned to neuropace for analysis.
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Event Description
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Patient presented with exposed lead wires resulting from erosion through intact (not adjacent to incision) skin near the lead site.Treatment included removal of the neurostimulator, lead, ferrule and bone flap.Antibiotics were also administered.
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Manufacturer Narrative
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(b)(4) the explanted product was not returned to neuropace for analysis.
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Event Description
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Patient presented with exposed lead wires resulting from erosion through intact (not adjacent to incision) skin near the lead site.Treatment included removal of the neurostimulator, lead, ferrule and bone flap.Antibiotics were also administered.
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Search Alerts/Recalls
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