In the Product Surveillance Registry (PSR), all reported lead-related adverse events are classified by the reporting investigator and are adjudicated by an independent event adjudication committee.

A lead-related complication is considered to have occurred if, 30 days or more after the implant, clinical observation is reported and a clinical action is taken.

The number of complications listed in the table are the actual numbers observed in the PSR centers around the world.

Click on Method for Estimating for more information.