FDA issues safety warning against premature battery depletion of pacemakers
The U.S. Food and Drug Administration has warned of premature battery depletion with certain Medtronic pacemakers and about serious consequences arising out of this.
Till now, the batteries of three devices drained prematurely, leading to the death of one pacemaker-dependent patient.
The U.S. Food and Drug Administration,FDA has issued a safety communication to all stakeholders to apprise them about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients.
Implanted cardiac pacemakers are battery-powered devices that provide pacing for slow heart rhythms and heart failure. In case it's capacitor is cracked, it may lose functionality and create an electric short, which can cause rapid battery depletion. If the battery runs out, the device will be unable to deliver life-saving pacing, which could lead to serious injury or death.
As a pay of its duty U.S. Food and Drug Administration FDA monitors for emerging safety concerns once a medical device is on the market and takes action when we become aware of issues that have the potential to put patients at risk.
To date, the U.S. Food and Drug Administration,FDA is aware of three events related to this issue where clinicians were unable to communicate with the device due to battery depletion resulting in loss of pacemaker function. One of the events resulted in the death of a pacemaker-dependent patient. Another patient experienced dizziness during follow-up and the clinician was unable to communicate with the device, which resulted in device replacement. These events occurred within a year of the device being implanted (average of 7 months); the devices are designed to last between approximately 7.5 and 15 years or 6 and 10 years before requiring battery replacement, depending on the device and the amount of pacing. The third event was identified prior to implant and therefore the patient was not adversely affected. Approximately 132,000 devices have been sold in the U.S. to date.
At this time, preventative (prophylactic) removal and replacement of affected devices is not recommended. Rather, patients and professionals should carefully monitor battery status using home monitoring systems. Due to the low frequency of device failure, the FDA believes these are appropriate mitigations for most patients, as patients could be at greater risk of complications from the surgical procedure required to replace the device. The FDA recently approved a new step in Medtronic’s manufacturing process developed to better detect capacitor failures in newly manufactured devices. Additionally, the agency approved Medtronic’s use of a different capacitor in newly manufactured devices to reduce the risk of premature battery depletion.