Model Number 3219 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Weight Changes (2607)
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Event Date 12/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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 is experiencing pain at the lead site.The patent is thin and has lost additional weight.The patient reports the leads are irritating her where she has clothing.In addition, the patient is not receiving effective stimulation (reference mfr.Report: 1627487-2017-08615) surgical intervention may be pending to address this issue.
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Event Description
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Follow up information identified the patient underwent surgical intervention on (b)(6) 2017 where the scs system was explanted.The system was functioning properly, however a bone spur was found upon physical assessment.The physician recommended to shave the bone spur down to prevent further pain at the lead site and relocate the lead; however the patient opted to have the entire scs system explanted.
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Search Alerts/Recalls
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