Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.

Reason: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

Code information: Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956

Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two (2) of which were implanted, see Attachment A.3 for list of serial numbers. There is 1 LSP112V device that is impacted by this issue, but this was distributed outside of the United States. See Attachment A.4 for list of OUS serial numbers.