Interstim Percutaneous Extension

Medtronic has identified eighteen reports where during the advanced evaluation trial period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway. This resulted in difficulty locating the percutaneous extension connector after the evaluation period when it is necessary to remove the percutaneous extension and external neurostimulator (ENS). In some cases of reported migration, an additional incision along the tunneling pathway has been required to disconnect the lead from the percutaneous extension. Patients may also be at an increased risk of procedural complications due to delays associated with troubleshooting. Additionally, if the chronic lead is damaged or displaced during the explant of the percutaneous extension, intraoperative replacement of the lead or an additional surgical procedure may be needed.

Recall start date: Mar 10, 2021