Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discharge (2225); Post Operative Wound Infection (2446)
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Event Date 08/27/2018 |
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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 3 of 4: reference mfr.Report: 1627487-2018-09352, reference mfr.Report: 1627487-2018-09353, reference mfr.Report: 1627487-2018-09354.It was reported (canada) the patient presented to the emergency room (er) due to increased pain, drainage and swelling at the lead site(s).The incision sites were cleaned and the patient was sent home with antibiotics.The patient returned to the er a few days later with continued symptoms and discharge at the anchor site.In addition, the patient experienced night sweats and chills.The entire system was explanted on (b)(6) 2018.
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Event Description
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Device 3 of 4: reference mfr.Report: 1627487-2018-09352 , reference mfr.Report: 1627487-2018-09353 , reference mfr.Report: 1627487-2018-09354.Follow-up identified the patient's infection was confirmed via cultures.
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Event Description
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Device 3 of 4 :reference mfr.Report: 1627487-2018-09352 , reference mfr.Report: 1627487-2018-09353 , reference mfr.Report: 1627487-2018-09354.Follow-up identified the infection has resolved after administration of antibiotics.
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Search Alerts/Recalls
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