Model Number 3788 |
Device Problem
Unintended Movement (3026)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 02/11/2015 |
Event Type
Injury
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Event Description
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Further follow up identified before the explant discomfort at the ipg site was present regardless of stimulation.Reportedly, the issue has resolved.
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Manufacturer Narrative
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Correction numbers: 1627487-07262012-002-r & 1627487-12192011-003-r.This ipg serial number was included in field advisories.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient (australia) experienced pain, swelling and ipg movement at the ipg pocket site.As a result, surgical intervention was undertaken to explant and replace the ipg.The physician electively explanted the ipg due to its age and recharge burden.The ipg device information is unknown at this time.
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Search Alerts/Recalls
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