Consumers and health professionals are advised that LivaNova, in consultation with the TGA, has issued a hazard alert regarding certain models of Platinum Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds). LivaNova is also recalling unused stock of these devices.
ICDs are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. CRT-Ds are ICDs that also coordinate the beating of the left and right ventricles to improve the heart’s blood pumping ability.
It has been identified that potentially affected models of Platinum ICDs and CRT-Ds may experience reduced longevity as a result of overconsumption of electrical current triggered by an electrostatic discharge. This can occur during the implant surgery or a magnetic resonance image (MRI) scan.
Importantly, these ICDs and CRT-Ds are not currently approved as MRI conditional and therefore patients with these devices normally should not undergo an MRI scan. However, LivaNova is aware that some patients have had MRI scans based on their treating physician’s assessment of the benefits and risks of the procedure.
The above issues do not otherwise affect the function of Platinum ICDs and CRT-Ds and can be detected upon interrogation of the device during a follow-up visit to the cardiologist. Overconsumption of current can be resolved by resetting the device.
A new software version for these devices has been developed and will resolve the above issues.
The potentially affected models are:
- Platinum VR 1210
- Platinum VR 1240
- Platinum DR 1510
- Platinum DR 1540
- Platinum CRT-D 1711
- Platinum CRT-D 1741
- Platinum SONR CRT-D 1811
- Platinum SONR CRT-D 1841
Information for consumers
LivaNova has contacted cardiologists and surgeons who have implanted potentially affected devices, providing further information about the above issues.
If you or someone you provide care for has a Platinum ICD or CRT-D implanted, your cardiologist will discuss this issue with you.
A new software version for these devices has been developed and will resolve the potential problem of overconsumption of current. All implanted devices will be automatically upgraded upon interrogation with a programmer updated with the new software.
If you have any questions or concerns about this issue, please contact your cardiologist.
Information for all health professionals
If you are treating a patient who has a potentially affected device, please be aware of this issue.
Reassure your patients that, other than the potential for reduced longevity, their devices will continue to function correctly. The issue should be resolved when they next see their cardiologist.
If they have any questions or concerns about this issue, refer them to their cardiologist.
Information for cardiologists.
LivaNova has contacted cardiologists who have implanted potentially affected devices, providing further information about the above issues including details of the recall procedure for unused stock of these devices.
If you are managing a patient who has a potentially affected device, it is recommended that a routine follow-up examination be done one month after implant and then every three months until it nears the replacement date.
Before discharging the patient and at each subsequent follow-up visit, it is recommended that you check the battery status of the device and the occurrence of system warnings. If the warning ‘[A3] Technical issue’ is displayed, then the device is affected by overconsumption caused by an electrostatic discharge at implant and needs to be reset. A second reset may be necessary to correct the estimation of the residual longevity displayed by the programmer.
If you have any questions or concerns about this issue, contact LivaNova on 03 9799 7444.
Source: TGA
