Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Implant Pain (4561)
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Event Date 09/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Device 2 of 2.Reference mfr report#1627487-2016-05252.It was reported the patient experienced swelling and pain at the lead incision site.In addition, her ipg's protruding through the ipg site and is causing pain as well.Reportedly, the patient was sent for lab work.Follow-up identified lab results were negative for infection.However, surgical intervention is scheduled as the next course of action to address the issue.
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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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Device 2 of 2.Reference mfr report#1627487-2016-05252.Follow-up identified surgical intervention was undertaken during which time the lead was explanted and replaced with a new model.Stimulation was effective 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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Device 2 of 2:
reference mfr report#1627487-2016-05252.Follow-up identified the issue is resolved.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Manufacturer Narrative
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An inaccurate h6 investigation conclusions code was inadvertently reported in previous report.Correct code has been updated in this report.
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Search Alerts/Recalls
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