Date of event and therapy date are estimated.During processing of this complaint, attempts were made to obtain patient weight.Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Related manufacturer reference number: 3006705815-2021-04134.It was reported the patient had impedance issues at the patient's lead contacts, and the patient lost effective therapy.As a result, surgery occurred in which the leads were explanted and replaced, which resolved the issue.
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