Model Number 3662 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 12/07/2017 |
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 1 of 2.Reference mfr report#1627487-2017-08771.It was reported that the patient experienced infection (site of infection unknown).As a result, surgical intervention was undertaken wherein the scs system was explanted on (b)(6) 2017.Culture results unknown.Antibiotic treatment unknown.
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Event Description
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Device 1 of 2, reference mfr report#1627487-2017-08771.Additional information received that patient was on oral antibiotics.It is unknown if infection resolved.Culture results were not available.
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Search Alerts/Recalls
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