MicroLead Safety

The lead is constructed of a very fine wire, approximately the same size as a human hair. The wire is coiled and has an insulated coating around it. It is possible that the small lead wire may fracture either during therapy or during the procedure to withdraw the lead at the end of therapy.  If a lead fractures, a remnant may be easily withdrawn, or it may remain beneath the skin.

In the vast majority of cases, the lead remnant will not result in any adverse effects and will not require removal. No medically serious events related to the use of the SPRINT PNS System have been reported.  According to a large study of similar leads the risk of infection associated with a lead remnant is rare, occurring in less than 0.3% of cases where a remnant remained. In rare cases removal under local anesthetic or use of an antibiotic may be required.

If a remnant of the MicroLead remains following the therapy the patient can be scanned safely in an MRI system under conditions described in the Instructions For Use document provided at the time of the lead implant procedure and made available on the Important Safety Information page.