Model Number 3386 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Erythema (1840); Fluid Discharge (2686)
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Event Date 07/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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The complaint of streptococcus cannot be confirmed via laboratory testing.(b)(4).Sjm 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.(b)(4).
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Event Description
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The patient had two anchors from the same lot.Device 2 of 4: reference mfr report #: 1627487-2016-04038, 1627487-2016-04123 and 1627487-2016-04124.It was reported the patient had a trial procedure on (b)(6) 2016.Following the procedure, the patient experienced drainage at the extension site and went to the emergency room where the dressing of the extension site was changed.On (b)(6) 2016, it was noted by the physician that the extension incision site looked red and infected.As a result, the lead was explanted and the patient was given antibiotics.Cultures were taken at the time and the results came back positive for a type of streptococcus.Follow-up revealed the patient was still on antibiotics.
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Manufacturer Narrative
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Sjm 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 2 of 4.Reference mfr report #: 1627487-2016-04038, 1627487-2016-04123 and 1627487-2016-04124.Follow-up revealed the patient was continuing to be on antibiotics and the physician believed it would resolve the infection.
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Manufacturer Narrative
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Sjm 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 2 of 4.Reference mfr report #: 1627487-2016-04038, 1627487-2016-04123 and 1627487-2016-04124.
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Search Alerts/Recalls
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