Related manufacturer reference number: : 3006705815-2020-00913, 3006705815-2020-00914,1627487-2020-04599.It was reported that patient experienced ineffective stimulation.During the lead revision procedure, it was revealed that the anchor holding the 9-16 contact lead had fractured, causing the lead to fracture as well.As a result, the lead and anchor were explanted and replaced, restoring the therapy.It is unknown which lead and anchor are liable for the issue.Hence, both leads, and anchors are made reportable.
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