Model Number 3788 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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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 scs ipg is inoperable (sjm representative confirmed the issue using external devices) after not being charged for an unspecified amount of time.As a result, surgical intervention was scheduled to address the issue.
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Event Description
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Additional information received identified the patient's scs ipg was explanted and replaced.Effective stimulation was restored with the surgical intervention.
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Search Alerts/Recalls
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