Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Post Operative Wound Infection (2446)
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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 5 of 5: reference mfr.Report# 1627487-2018-07486.Reference mfr.Report# 1627487-2018-07487.Reference mfr.Report# 1627487-2018-07488.Reference mfr.Report# 1627487-2018-07489.It was reported (b)(6) the patient experienced infection at the lead and ipg wound site and was on antibiotics course.The physician concluded the wounds were not healing properly due to scar tissue.Surgical intervention may be taken at a later date to address the issue.Device information for anchors are unknown at this time.
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Event Description
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Device 5 of 5 : reference mfr.Report# 1627487-2018-07486 , reference mfr.Report# 1627487-2018-07487 , reference mfr.Report# 1627487-2018-07488 , reference mfr.Report# 1627487-2018-07489.
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Search Alerts/Recalls
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