Model Number 3116 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Type
Injury
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Event Description
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It was reported that a patient¿s device helped at the beginning, but the patient didn¿t think it was helping anymore.The device was going to be removed because it wasn¿t working anymore, was not functioning, and it hadn¿t worked properly for a long time.The patient was scheduled to have her colon removed at the same time, the device would cause issues while removing the colon because it was in the way, and it would be removed all at once.No outcome was reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.
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Manufacturer Narrative
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Concomitant products: product id 435135, serial# (b)(4), implanted: (b)(6) 2006, product type lead; product id 435135, serial# (b)(4), implanted: (b)(6) 2006, product type lead.(b)(4).
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Event Description
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It was reported the patient had never had therapeutic effect.The patient wanted the system explanted due to not getting any therapeutic benefit.It was later reported that the patient had their neurostimulator and leads completely removed on (b)(6)-2014.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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