Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Vomiting (2144); Post Operative Wound Infection (2446)
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Event Date 07/08/2015 |
Event Type
Injury
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Event Description
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The patient received two scs leads with the same lot number.It was reported, the patient ((b)(6)) experienced nausea and vomiting.Additionally, the patient's wound appeared red and sore due to possible infection at the lead incision site.Reportedly, the patient was being treated with antibiotics (flucloxacillin).No additional information available at this time.
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Manufacturer Narrative
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(b)(4).Evaluation: method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.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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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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Further follow up identified infection has resolved.
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Search Alerts/Recalls
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