Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Increased Sensitivity (2065)
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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.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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Device 2 of 2: reference mfr.Report# 1627487-2018-07273.It was reported the patient experienced pain/tenderness at the scs anchor site.Surgical intervention may be taken later to address the issue.
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Event Description
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Device 2 of 2.Reference mfr.Report# 1627487-2018-07273.Additional information received identified the patient underwent surgical intervention on (b)(6) 2018 wherein the physician buried the patient's anchors deeper.
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Search Alerts/Recalls
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