Related manufacturer report number: 3006705815-2022-15958, 1627487-2022-04280, 1627487-2022-04281, 1627487-2022-04392, 1627487-2022-04393, 1627487-2022-04394, 1627487-2022-04395, 3006705815-2022-16070, 1627487-2022-04396, 1627487-2022-04397, 1627487-2022-04398.It was reported an infection was present at the ipg site.Patient was prescribed oral antibiotics.The patient's cervical scs and dbs system were later explanted due to infection.
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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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