The Central Drugs Standards and Control Organisation (CDSCO) has issued a warning to consumers that a number of pacemakers manufactured by US firm Medtronic could be faulty. The CDSCO joins other medical device regulators including the US Food and Drug Administration (USFDA) in encouraging caution about the devices and exhorting consumers to be vigilant and look out for symptoms which could suggest the device suddenly losing battery.
Three products by the Minnesota-based medical device giant are covered in a nationwide alert issued by the CDSCO, with battery drainage being the cause behind the red flag being raised. A pacemaker is a device used to treat cardiac arrhythmia, a condition where the heartbeat is abnormal. The pacemaker sends electrical signals to help the heart to beat regularly. Research suggests that being fitted with a pacemaker can restore life expectancy if heartbeat is too slow.
People fitted with Medtronic pacemakers are being encouraged to seek medical attention if they experience symptoms such as light-headedness and loss of consciousness, as this could be a signal of sudden battery drainage. Despite the CDSCO and USFDA’s warnings, the firm says the product has not been recalled and that it has received only three complaints about its products out of 266,700 distributed worldwide, of which none came from India.
“We have and continue to communicate proactively with the doctors and relevant stakeholders in India and have informed them about the performance note,” Medtronic said in a statement. “There have been no patient issues reported in India.”
The firm encouraged doctors not to resort immediately to pacemaker replacement. Instead, they “advise physicians to continue normal patient follow-up in accordance with standard practice and, where possible, to continue with remote monitoring.”
Data as to how many people in India are fitted with devices such as pacemakers is limited, although cardiovascular diseases such as arrhythmia are now widely understood to be the leading cause of mortality in India and increasing in prevalence. Ensuring patient safety in the treatment of such conditions is as important as ensuring devices and other treatments are safe for purpose. Vigilance on the part of India’s medical regulators, therefore, is vital.