Model Number 3186 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 02/11/2012 |
Event Type
Injury
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Event Description
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It was reported the patient experienced unintended stimulation.Fluoroscopy did not reveal any anamolies with the lead.Surgical intervention will be taken at a later date to address the issue.
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Event Description
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It was reported the patient had a lead revision surgery on (b)(6) 2015 where the lead was repositioned.Reportedly, effective coverage was restored postoperatively.
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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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Search Alerts/Recalls
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