Patient was experiencing pain at the implant site.Saw implanting doctor on (b)(6) 2022 found seromas at both the ipg site and lead site.Fluid was drained.Lab results indicated a rare gram-positive bacillus ¿ beaded.It was reported the patient went to the emergency room on (b)(6) 2021 and had system explanted.Patient was hospitalized for eight days to treat infection.Related manufacturer reference number: 3006705815-2022-18091, 3006705815-2022-18092, 3006705815-2022-18093, 3006705815-2022-18094.
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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