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 12/18/2015 |
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 per the physician's notes that the scs system 'has not functioning for quite some time'.X-ray imaging did not reveal any anomalies.Surgical intervention is planned as the next course of action.
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Event Description
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Follow-up identified the patient's ipg was explanted and replaced.Effective stimulation was restored post-operatively and the system was reportedly functioning 'properly'.
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Search Alerts/Recalls
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