¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information.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 numbers: 3006705815-2021-03487, 3006705815-2021-03488, 1627487-2021-15672.It was reported that the patient was diagnosed with infection at the lead sites.As a result, surgical intervention occurred during which the leads were explanted and the patient was prescribed antibiotics to address the issue.
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