Device 3 of 3.Ref mfr reports: 1627487-2014-01472, 01473.It was reported the pt is without left side stimulation.The pain pattern is bilateral back and legs.After further investigation, it was revealed the lead has migrated from t8 to t11.No known traumatic events have occurred.Surgical intervention was undertaken on (b)(6) 2014 in efforts to revise the leads.During procedure, the physician noted purulent drainage and puss extending from the lead and ipg sites.Subsequently, the physician opted to explant the scs system.Cultures were taken, however, results are unk at this time.
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Evaluation: 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 device was reworked 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 info 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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