Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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Event Date 08/09/2014 |
Event Type
Injury
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Event Description
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It was reported the patient is not receiving effective stimulation.Lead diagnostics were normal; however, reprograming was unable to resolve the issue.Fluro-images indicated the lead has migrated up.Since the implant, patient stated she has suffered multiple falls and a left hip surgery.The patient is suffering from several other medical issues for which the patient is addressing prior to her scs system.
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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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Follow up information identified surgical intervention may be pending 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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Follow up information identified the patient underwent surgical intervention where her entire scs system was removed.
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Search Alerts/Recalls
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