Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Swelling (2091); Discomfort (2330)
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Event Date 03/25/2016 |
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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Device 2 of 2.Reference mfr report #1627487-2016-01849.It was reported the patient experiences increased sensitivity and swelling at the lead incision site and stimulation increases the issues.Follow up revealed the patient continues to have intermittent swelling.Surgical intervention may be taken to address the issue.
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Event Description
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Device 2 of 2.Reference mfr report #1627487-2016-01849.It was reported the patient's symptoms resolved without intervention.
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Search Alerts/Recalls
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