CareLink SmartSync� Device Manager supporting Cobalt� and Crome� ICDs and CRT-Ds
Original Date of Communication: October 2021

View specific models that this applies to

STATUS UPDATE - MAY 2023

Through 11 April 2023, Medtronic has confirmed 31 reports of a software interrogation failure due to this issue out of approximately 128,467 devices distributed worldwide (0.024%). No permanent patient harms have occurred.

ORIGINAL COMMUNICATION - OCTOBER 2021

This communication provides notice of a software update for CareLink SmartSync™ Device Managers (SmartSync) to correct the potential for a small number of SmartSync interrogation sessions, or CareLink network transmissions to fail due to a software error. The issue described below can only occur with Medtronic Cobalt™ and Crome™ implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds) when the current session data includes diagnostic episodes with a specific type of VT/VF therapy sequences.

Please install application software D00U005 version 5.0.0 (or higher) on all SmartSync tablets in your facility. This software update ensures SmartSync tablets will interrogate all episode and data types for all programmer sessions. No programming or reprogramming of devices is required.

ISSUE DETAILS

With prior software versions, 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. For both of these scenarios Medtronic Technical Services can assist clinicians with retrieving stored device information for the failed transmission.

Through 24 Sep 2021, Medtronic has confirmed 22 reports of a software interrogation failure due to this issue out of approximately 48,700 devices distributed worldwide (0.045%). No permanent patient harms have occurred.

No device operations are affected by the software error. 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 Care Alerts, or inability to access stored device diagnostic information until a SmartSync tablet with the updated software is located, and a new session can be established.

The SmartSync software release D00U005 version 5.0.0 is available for immediate download on to all tablets. (Software availability varies by geography.) A CareLink software update is anticipated to be released in mid-2022.

PATIENT MANAGEMENT RECOMMENDATIONS

We realize that each patient requires unique clinical considerations. Medtronic recommends physicians follow normal clinical practices given these devices will continue to operate as programmed:

If a failure to interrogate a Cobalt or Crome device occurs with a SmartSync programmer, confirm that the SmartSync application software has been updated to D00U005 version 5.0.0 (or higher). Contact your Medtronic representative or Tachy Technical Services at 800-723-4636 for assistance with retrieving the session data.

Note: Cobalt and Crome devices are only supported by the SmartSync programmer; these devices are not supported by the Model 2090 and Encore programmers.

If a CareLink transmission is attempted, but the transmission is not viewable on the CareLink network (i.e., the transmission is missing from the transmission list for the patient), contact Medtronic Technical Services at 800-723-4636 for assistance. This team can help with retrieving the transmission data and/or provide additional troubleshooting guidance that may be needed. Missing transmissions can occur due to connectivity or other issues and may be unrelated to the software decode error described in this letter.