In the Product Surveillance Registry (PSR), all adverse events are critically evaluated by a Medtronic technical review committee and the investigator is asked to assess the relationship of the adverse event to the presence or performance of the implanted system, generator and/or lead(s).

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.