Note: Firmware update resolving the issue August 2017.
Note: Firmware update resolving the issue confirmed March 2019.
Risk of RF interference causing inappropriate in-clinic programming.
This advisory describes a battery malfunction with the St. NanoStim™ Leadless Cardiac Pacemaker (LCP) system.
This advisory relates to an increased risk of premature, and possibly sudden, battery depletion with the St. Jude Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra ICDs manufactured before May 23, 2015.
Devices manufactured after May 23, 2015 are not affected by this advisory.
CD1411-36Q / CD2411-36C / CD2377-36QC
CD1411-36C / CD1377-36QC / CD2377-36C
CD2411-36Q / CD1377-36C
Delay or loss of high voltage therapies may occur subsequent to the rare circumstance of 3 “simultaneous” events, which can be corrected with an anticipated software release.