Model Number 3186 |
Device Problem
Low impedance (2285)
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Patient Problems
Swelling (2091); Inadequate Pain Relief (2388)
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Event Date 01/20/2016 |
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 #1627487-2016-01181.It was reported the patient experienced low impedances and swelling at the ipg and lead sites.The patient's stimulation was turned off and the physician gave the patient steroid injections and muscle relaxants.Follow-up revealed the swelling has decreased.Images were taken which revealed the lead had migrated.Surgical intervention is planned to address the issue.
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Event Description
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Device 2 of 2.Reference mfr report #1627487-2016-01181.It was reported the patient's leads were explanted and replaced.The patient was programmed and reportedly receives effective stimulation.
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Search Alerts/Recalls
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