Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Seroma (2069); Discomfort (2330)
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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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 4.Reference mfr.Report#s: 1627487-2017-07825; 1627487-2017-07830; 1627487-2017-07831.It was reported ((b)(6)) the patient experienced discomfort at the anchor site due to possible seroma.Surgical intervention may be taken at a later date to addressed issue.
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Event Description
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Device 1 of 4 : reference mfr.Report# 1627487-2017-07825 , reference mfr.Report# 1627487-2017-07830 , reference mfr.Report# 1627487-2017-07831.Additional information received identified the patient underwent surgical intervention on (b)(6) 2017 where in the seroma was drained.Also during the surgery the leads were repositioned and the anchors were explanted and replaced.As of (b)(6) 2018 the patient still had some discomfort.
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Event Description
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Device 1 of 4.Reference mfr.Report# 1627487-2017-07825, reference mfr.Report# 1627487-2017-07830, reference mfr.Report# 1627487-2017-07831.Additional information received identified the issue has resolved.
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Search Alerts/Recalls
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