Fridley, Minn.-based Medtronic said in the notice out of Germany that the Medtronic Model 3560030/3560022 percutaneous extension is intended for use with the Model 978A1/978B1 InterStim SureScan MRI leads during an advanced evaluation to screen potential candidates for chronic sacral neuromodulation therapy.
The company has identified 18 reports in which, during that evaluation period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway, which resulted in difficulty locating the connector when it is necessary to remove the extension and external neurostimulator.
In some reported cases, an additional incision along the tunneling pathway was required to disconnect the lead from the extension, while patients may also be at an increased risk of procedural complications due to the delays associated with troubleshooting the issue.
Should the lead be damaged or displaced, intraoperative replacement of the lead or an additional surgical procedure may be necessary, the company said.
Medtronic included instructions in the notice that instruct users to complete solutions such as looping a suture around the connector and extension body before creating a subcutaneous pocket perpendicular to the extension tunneling path, or other measures that are explained in full with diagrams.