Model Number 3788 |
Device Problems
Nonstandard Device (1420); No Device Output (1435)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/01/2016 |
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 was unable to establish communication between her ipg and multiple external devices.A sjm representative confirmed the issue.Surgical intervention will be taken at a later date to address the issue.
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Event Description
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Further follow up identified the ipg was explanted and replaced which resolved the issue.Reportedly, stimulation was restored postoperatively.
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Search Alerts/Recalls
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