Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Discomfort (2330); Inadequate Pain Relief (2388); Weight Changes (2607)
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Event Date 03/01/2016 |
Event Type
Injury
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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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The patient received two leads with the same lot number.It was reported the patient experienced ineffective stimulation.Surgical intervention will take place to address the issue.
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Event Description
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Follow-up identified the patient underwent surgical intervention to explant the leads.The leads were cut during the procedure due to the presence of scar tissue.
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Search Alerts/Recalls
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