New Delhi: Accounting for the safety efficacy, India’s apex drug regulator Central Drugs Standard Control Organisation (CDSCO) has issued an advisory for patients and health care providers against three models of pacemakers sold by the world’s largest medical device manufacturer, Medtronic.
According to recent media reports, CDSCO has red flagged three brands of pacemakers manufactured by US-based medical device maker Medtronic. CDSCO’s alert mentions three of the five models flagged by USFDA that are used in India namely Astra, Serena CRT-P and Solara CRT-P.
The development comes days after the US health regulator raised alarm about the malfunction in Medtronic pacemakers. As per the USFDA alert, three medical device reports in the USA, in which a Medtronic implantable pacemaker or cardiac resynchronization therapy pacemakers (CRT-P) battery had fully drained because of a crack in the device’s capacitator, without any warning to the patients or health care providers. If a capacitator in an implanted pacemaker is cracked, it can create an electric short that can cause a battery to drain earlier than expected.
Medical Dialogues had earlier reported that USFDA had issued safety alarm about premature battery depletion without warning patients or health care providers in certain Medtronic pacemaker models, which could lead to devices losing power quickly and triggering a medical emergency.
As on date, 1,850 such devices have been imported to India, of which 1,600 have been sold. However, no adverse events have been reported in the country so far, according to the Indian arm of the US medical device giant. The adverse events were reported in the USA within one year after patients were implanted with the pacemaker. They were reported on average within seven months of the device getting implanted.
CDSCO has now issued an advisory to warn people concerned against the reported malfunction.
The advisory informs that those involved should be aware of sudden battery levels drop during follow up visits. Patients must watch out for signs such as feeling lightheaded, dizzy, chest pain, severe shortness of breath.
“We are asking them (Medtronic) to communicate this alert to all patients who got implanted with this device,” a senior health ministry official told The Indian Express on condition of anonymity.
Once the patient has been called, the pacemaker should be checked and the patient should be informed about the future precautions. Thus, safeguarding liability.
The advisory further states that 1600 is a small number, therefore all 1600 patients should be tracked and evaluated for the battery function. Once found ok their battery should be checked every month ( normally it is one a year).
It is stated that if the patients require implant it should be provided for free by the company while in case of any default, adequate compensation should be given to the patient. Any failure of pacemaker resulting in complete heart block and death will end up with huge liability for the doctor, hospital and the company.
Citing the seriousness of the issue, it has been further stated that once possible complication is known and no action is taken in time which results in any fatality will attract 304A. Section 304A of the Indian Penal Code talks about the punishment entailed with death caused by negligence.
CDSCO has issued an alert to healthcare providers, cardiac patients and medical device distributors to prevent safety issues with these models.
However, talking to the daily, a spokesperson for the company told The Indian Express, “Medtronic India has not yet received any communication about an alert from Central Drugs Standard Control Organisation.”
Addressing patient concerns on whether they needed to go in for revision surgeries, Medtronic’s spokesperson told The Indian Express, “In consultation with our Independent Physician Quality panel, we do not recommend device replacement and advise physicians to continue normal patient follow-up in accordance with standard practice, and where possible, to continue with remote monitoring. While the devices continue to perform well within reliability projections, Medtronic has implemented additional process and component enhancements that have been reviewed and approved by the FDA.”
Prior to this, USFDA in its alert mentioned the death of one patient as a result of the damaged device while another patient experienced dizziness in a follow-up that led to a device replacement.
Furthermore, pertaining to the issue, Medtronic’s official statement reads, “According to a performance note on the five pacemakers and CRT-Ps, only three complaints were received out of over 2.60 lakh devices distributed worldwide since February 2017,”
“The projected rate of occurrence for this issue is 0.0028 per cent, with the most susceptible period being the first 12 months after a device is implanted,” the statement added.
DCGI has also stated that floating a National advertisement for the same is not required.