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 10/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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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 no longer receiving stimulation and was unable to charge her scs ipg.An sjm representative confirmed the device was inoperable.As a result, the scs ipg was explanted and replaced with a different model which resolved the issue.
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Manufacturer Narrative
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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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