Model Number 3186 |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 03/23/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2015-20212.It was reported the patient ((b)(6)) experienced ineffective and unintended stimulation.X-rays showed that the lead had migrated.Surgical intervention will be taken at a later date to address the issue.The patient received three scs leads.Two of them has a same lot # 4155066.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2015-20212.Further follow up identified the patient's scs system was explanted as the patient needs to have mri and fusions.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2015-20212.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2015-20212.
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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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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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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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Manufacturer Narrative
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Inadvertently reported as product returned.The entire lead body segments were not returned.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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