Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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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.Manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported ((b)(6)) the patient experienced pain at the lead site.The physician determined local inflammation and the leads were explanted (explant date unknown).The ipg was left implanted with the port plug in place.Device information including the number of devices involved is unknown at this time.Additional devices may be added at a later date once the information is available.
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Event Description
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Device 1 of 2 reference mfr.Report# 1627487-2018-02688.Additional information received identified the leads were explanted which resolved the issue.Another lead is added as device 2.
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Search Alerts/Recalls
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