Model Number 3788 |
Device Problem
No Device Output (1435)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/29/2016 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported the patient's ipg is inoperable.As a result, surgical intervention may be undertaken as the next course of action to address the issue.
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Event Description
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Follow-up identified surgery took place on (b)(6) 2016 during which time the ipg was explanted and replaced.Effective stimulation was achieved postoperatively.The issue was resolved.
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Search Alerts/Recalls
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