Related manufacturer reference number: 1627487-2023-04532.It was reported that during an ipg replacement revision procedure on (b)(6) 2023 due to normal end of life, one of the leads had high impedance.In turn, the lead was explanted and replaced with a new lead to address the issue.When explanting the lead with high impedance the other lead was also pulled.Hence, the second lead was also explanted and replaced.Impedance were normal post op and therapy was confirmed.Investigation was unable to determine which of the leads had high impedance and which one was pulled.
|