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).Field advisory: 1627487-07262012-002-r.This ipg serial number was included in field advisories.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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The patient reported he is unable to establish communication between his scs ipg and external devices for at least 2 months (date of event is unknown) after turning stimulation off with his magnet and not charging for at least 4 months.An sjm representative confirmed the scs ipg is inoperable.Surgical intervention will be taken at a later date 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 with a different model.Stimulation was restored following the surgical intervention.
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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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