So far, none of the Indian patients have faced any adverse effects. Meanwhile, the Central Drugs Standard Control Organisation can keep the public informed of any further updates.
Big alert for healthcare providers, heart patients, and medical device distributors! According to an IE report, the Central Drugs Standard Control Organisation (CDSCO) has issued an alert on Saturday related to measures that are needed to be taken to prevent safety issues with three models of Medtronic’s pacemakers.
This alert from India’s apex drug regulator comes exactly one week after the US Food and Drug Administration (US FDA) had already flagged five such models of Medtronic’s pacemakers and cardiac resynchronization therapy. pacemakers due to concerns about their batteries.
According to the US regulator, the issue had led to a patient’s death. Following this, on May 7, the US FDA issued the alert with details pertaining to a Medtronic implantable pacemaker, that had “fully drained” out due to a crack in the device’s capacitor.
The US FDA raised concerns that if one of the components of a capacitor is cracked, it can lose its functionality and create an electric short. This, in turn, can cause a rapid battery depletion.
However, there is no reason to panic. Medtronic has published a performance note related to a rare mode in the population of its Azure and Astra pacemakers as well as Percepta, Serena and Solara cardiac resynchronization therapy pacemakers. Stating that they have received three complaints out of 266,700 devices that have been distributed worldwide since February 2017.
Further to this, Medtronic states that the projected rate of occurrence to the issue is 0.0028 percent, with the most susceptible period being the first twelve months after the device is implanted.
According to Medtronic’s Independent Physician Quality panel, they do not recommend device replacement and have advised physicians to continue normal with remote monitoring, given that the devices continue to perform well with reliability projections.
Medtronic also stated that an additional process and component enhancements have been renewed and approved by the FDA. In India, Astra pacemaker, Solara CRT-P, and Serena CRT-P are available, which Medtronic assures that they will continue to keep all stakeholders informed.
A key factor that Medtronic points out is that there have been no patient issues reported in India related to the performance note and that it is not a case of the product recall. The company emphasizes that it is in talks with the Central Drugs Standard Control Organisation in India, as they are strongly committed to the safety and well being of their patients.
From the US FDA statement, it is clear that a greater danger arises from the fact that it can trigger an instant electric short without any warning. This can drain the battery, rendering it ineffective for patients who are on life-saving devices such as pacemakers.
For now, the FDA has recommended to healthcare providers to continue to let patients use remote monitors and not advise against prophylactic removal and replacement of devices unless necessary.
Further, the FDA has also stated that physicians should opt to replace pacemaker or CRT-P used by their patients immediately, following ERI alert. Simply put, an ERI alert refers to a notification that informs patients when the battery level drops down below a specific limit.
Also, three out of the five models flagged are used in India, namely – Astra, Solara CRT-P and Serena CRT-P. So far, none of the Indian patients have faced any adverse effects. Meanwhile, the Central Drugs Standard Control Organisation can keep the public informed of any further updates.