In the first weeks following lead implantation, physiologic responses and lead performance can vary until long-term lead stability is attained. It is for this reason that the Product Surveillance Registry (PSR) 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 US Acute Lead Observations table. The source for this information is Medtronic‘s complaint handling system database.
The lead event reported to Medtronic may or may not have involved clinical action or product returned to Medtronic. The lead may have remained implanted and in service.
Click on Method for Estimating for more information.