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 03/03/2015 |
Event Type
Injury
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Event Description
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Further follow up identified the leads were explanted and replaced which resolved the issue.Reportedly, the patient has effective stimulation postoperatively.
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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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It was reported the patient experienced ineffective and unintended stimulation.Surgical intervention will be taken at a later date to address the issue.The patient received two leads with the same lot number.
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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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Search Alerts/Recalls
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