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 Type
Injury
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Manufacturer Narrative
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(b)(4).This ipg serial number was included in field advisories:
1627487-07262012-002-r.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 (date of event is unknown).As a result, surgical intervention will be taken at a later date to address 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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Event Description
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Additional information received identified the patient's scs ipg was explanted and replaced with a different model.Stimulation was restored with the surgical intervention.
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Search Alerts/Recalls
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