Model Number 3228 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/13/2014 |
Event Type
Injury
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Event Description
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Device 1 of 2 reference mfr report#1627487-2014-01832.It was reported the patient was involved in a recent motor vehicle accident.As a result, stimulation was lost.Reportedly, reprogramming was attempted to no avail.However, diagnostic testing was normal.X-rays were taken and reveal the lead has pulled out of the ipg header.Surgical intervention may be undertaken as the next course of action to address the issue.
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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.
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Event Description
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Device 1 of 2 reference mfr report#1627487-2014-01832 follow-up identified surgical intervention was undertaken, explanting and replacing both the lead and ipg.Reportedly, fluid was observed in the header of the ipg.Effective stimulation was achieved postoperatively.The issue is resolved.
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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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