In the first weeks following implantation, physiologic responses and product performance can vary until long-term lead stability is attained. It is for this reason that the survival probability results, which are intended to measure long-term performance, do not include complications that occur within the first 30 days after implant.

Information about the clinical experience in the first month of service is included in the Acute Observations table. The source for this information is Medtronic‘s complaint handling system database.

The event reported to Medtronic may or may not have involved clinical action or product returned to Medtronic. The product may have remained implanted and in service.