Potential for Intermittent-Reduced-Energy Shock Due To Short Circuit Protection Event
Cobalt™ XT, Cobalt™ and Crome™ ICDs and CRT-Ds
Original Date of Communication:
STATUS UPDATE - AUGUST 2022
As of 10 August 2022, a software release is now available for CareLink™ SmartSync™ Device Managers (SmartSync). Once a SmartSync tablet has been updated with software application D00U005 version 7.1.1 (or higher), the programmer will deploy a device update to Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to prevent the potential for an intermittent, second-phase Short Circuit Protection (SCP) event during high-voltage (HV) therapy delivery. This software update was previously announced as part of an advisory communication Medtronic issued in June 2022 (see original communication posted below).
Through 05 August 2022, Medtronic has confirmed 41 devices, out of approximately 89,500 devices distributed worldwide (observed rate 0.05%) have experienced a second-phase SCP event. This rate remains within the projected rate expected to occur within 24 months for devices without the software update installed. Medtronic has not received any reports of permanent harm or death due to this issue.
Medtronic representatives are available to work with clinicians to ensure all SmartSync tablets in their facility(s) are updated with application software D00U005 version 7.1.1 (or higher). The software can be installed by connecting each SmartSync tablet to the internet, opening the SmartSync App and accepting the on-screen prompts.
As disclosed in the June 2022 patient management recommendations, patients will require an in-clinic visit for the update to be installed into their device via interrogation with an updated SmartSync tablet. Once installed, the update will allow devices to deliver the full programmed shock energy. Programming B>AX pathway and Active Can enabled is still required. On-screen messaging will reinforce these programming recommendations. Additionally, this programming mitigates the theoretical risk for proarrhythmia if a low-level current pathway develops in the HV circuitry.
Clinicians can identify if a patient’s device has successfully received the update by viewing the displayed Configuration ID and confirming the first number in the sequence is as indicated below:
- 11-1-0 for Cobalt/Crome VR devices
- 10-1-0 for Cobalt/Crome DR and CRT-D devices
The Device Configuration ID can be found under the “Device Information” section of the SmartSync Parameters Report, or for CareLink patients, under the Transmission Details page by selecting <More Reports > ‘Parameters.’
ORIGINAL COMMUNICATION – JUNE 2022
This communication provides notice of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Through 03 June 2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a Short Circuit Protection (SCP) alert. Medtronic has not received any reports of permanent harm or death due to this issue. Medtronic has submitted a device software update to address this issue and anticipates it will be available for download into implanted devices <beginning third/fourth quarter of calendar year 2022>, pending regulatory approvals.
Short Circuit Protection (SCP) alerts trigger during HV therapy during the first- or second-phase of the HV biphasic waveform delivery. This communication focuses on second-phase SCP events that are the result of a secondary, low-level current pathway detected in the HV circuitry.
- A second-phase SCP event will deliver approximately 79% of programmed energy as a monophasic waveform.
- Defibrillation efficacy is reduced by ~1%for this type of SCP event when HV therapy is programmed to 40J, considering cumulative success across the full series of shocks (Rx1 through Rx6).
Based on analysis of peer-reviewed literature as well as CareLink data on shock efficacy from more than 279,000 episodes*, termination success rates for 32J (~79% of 40J), monophasic shocks versus 40J biphasic shocks are estimated in Table 1. Termination success may vary depending on individual patient risk factors and medication use.
While 0.03% has been observed to date, Medtronic projects 0.18%** of the ~80,000 distributed devices may experience a second-phase SCP event within 24 months of service life, when considering the probability for these SCP events increases over time, and the likelihood a patient will need HV therapy during that time.
- For the population of patients who received HV therapy, the observed rate was 0.77%. When projecting for this population, the chance of encountering a second-phase SCP event is ~5.0%** at 24 months.
**The above projections are based on calculations without the planned device software update. Once installed, this update, in addition to the programming recommendations, will resolve occurrences of second-phase SCP events.
Potential harms related to a second-phase SCP event include failure to terminate the arrhythmia due to reduced-delivered-energy, a theoretical risk of proarrhythmia, and complications associated with device replacement, including unnecessary lead replacement due to misinterpretation of the SCP alert.
- While not observed clinically, Medtronic estimates the risk for proarrhythmia is 0.002% in the AX>B configuration, and improbable in the B>AX configuration (less than 0.00004%), with Active Can pathway enabled. These risks may be higher when Active Can is disabled.
The overall risk for patient mortality due to this issue is estimated to be 0.002% at 24 months when combining the likelihood a patient will need therapy with the probability an arrhythmia fails to terminate after six sequences of 32J monophasic shocks.
- Comparatively, the risk of patient mortality due to complications associated with device replacement is 0.032% - 0.043%1,2,3
PATIENT MANAGEMENT RECOMMENDATIONS AND CONSIDERATIONS:
SCP events are evident to the patient and clinician. Devices will issue an audible tone and, for patients enrolled in CareLink, a wireless CareAlert will report RV Defib lead impedance 0 ohms.
Medtronic recognizes that each patient requires unique clinical considerations. Based on internal investigation and external consultation with our Independent Physician Quality Panel (IPQP), Medtronic recommends:
- Prophylactic device replacement is NOT recommended.
Remote monitoring with normal frequency of follow-up per clinic protocol, with patients’ next follow-up scheduled in-clinic to allow for device reprogramming (if necessary):
- Programming all HV therapies to 40J with a B>AX pathway and Active Can/SVC Coil set with Active Can enabled across all therapy zones.
Contact Medtronic Technical Services (1-800-723-4636) or your local representative if an RV Defib Lead Impedance Alert reporting zero (0) ohms is observed – as this is an indicator that an SCP event was detected during HV therapy.
- Importantly, if the delivered energy during the episode is ~79% of the programmed energy AND the SCP alert indicates an RV Defib Lead impedance alert reporting exactly zero (0) ohms, this is an indication of a second-phase SCP event (as described in this letter) and not a lead issue.
Consider device replacement only after observing and confirming the cause of an SCP event with a Medtronic representative, with the understanding a device has an ~81% probability of delivering subsequent reduced-energy shocks, and with the understanding an update for implanted devices is anticipated to be available beginning <third quarter/fourth quarter> of calendar year 2022.
Note: The software update will require an additional in-clinic follow-up in order for it to be installed into a patient’s device. The update will ensure the full shock energy is delivered in the presence of a secondary, low-level current pathway in the HV circuitry.
- After an SCP event, pacing, sensing, episode detection, and anti-tachycardia pacing (ATP) therapies are not impacted; additionally, HV charging, battery longevity and Bluetooth telemetry are not impacted.
1 Tarakji KG, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. The New England Journal of Medicine. 2019; 380(20):1895-1905.
2 Medtronic Data on File. MDT2260884-CRHF CIED Infection Report; Agile: MDT2260884, Version 2.0, 11/02/2015.
3 Birnie D, et al. Complications associated with defibrillation threshold testing: The Canadian experience. Heart Rhythm. 2008; 5(3):387-90.