Returned Product Analysis Neuromodulation Product Performance

Registry devices that are returned to Medtronic are analyzed via a Returned Product Analysis (RPA) process following protocols to confirm proper functioning or identification of root cause for any failure or deficiency. For registry pumps and neurostimulators that are returned, and for which RPA establishes a root cause or finds no anomaly, results reported herein reflect the RPA finding unless otherwise indicated in this report. When available, RPA findings are also used as one of the sources to identify the root cause of failure or deficiency for catheters and leads. In cases where the center does not explant and/or return a device, the physician-reported event reason is used for classification and analysis purposes.

Medtronic uses data from RPA as well as complaint reports from non-returned product for ongoing quality monitoring and improvement efforts. This report presents data from the registry including the results of RPA for returned devices from registry centers and patients. Data from RPA outside the registry centers and patients are not presented in this report.