A small number of Smartsync interrogation sessions, or Carelink network transmissions may fail for cobalt or crome devices when the current session diagnostic data includes any VT/VF episode type with multiple therapy sequences and three or more data recording suspensions. For these specific episodes, the software is unable to decode and process the data. Smartsync will display a message indicating an "unexpected error occurred", and the application software requires restarting. Within Carelink, the current transmission processing may fail, and the information will not be viewable. No device operations are affected by the software interrogation issue. All device features and therapies continue to operate as programmed. Risks associated with an interrogation failure are potential for unnecessary device replacement, and/or delays in patient care due to missed Carealerts, or inability to access stored device diagnostic information in a timely manner. Recall start date: 2021-10-21
RecallTracker