Device 1 of 2.Ref mfr.Report: 1627487-2014-26336.The pt was implanted with a surgical scs lead two lead extensions from the same lot number.It was reported the pt experienced fever and chills.As a result, the pt's lead and lead extensions were explanted.Cultures were taken however, results are unk.The pt was prescribed iv antibiotic therapy to address the reported issue.
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Method: the device history and sterilization records were reviewed.Results: review of the dhr found a nonconformance related to the product lot.However, the individual affected devices were reworked or removed and all devices within the lot met acceptance criteria.Therefore, the dhr anomaly is not related to the alleged device complaint.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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