Date of event is estimated.During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.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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Related manufacturer reference number: 3006705815-2021-04971, 1627487-2021-17555, 1627487-2021-17557.It was reported the patient accidently cut the lead.As a result, the physician decided to explant the entire scs system due to concerns of possible infection.Patient treated with oral antibiotics.
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