Medtronic InSync III Pacemaker Recall Issued Due to Defective Battery Risk

Almost 100,000 Cardiac Resynchronization Therapy (CRT) Pacemakers distributed globally by Medtronic are being recalled, after reports suggest the device batteries may put out less power than necessary to activate them in case of a medical emergency. 

A Medtronic InSync III pacemaker recall was announced by the FDA, after the manufacturer received at least 30 confirmed reports of battery malfunctions.

If the pacemaker battery fails, the device may not receive necessary power to function properly. At least one death has been linked to the Medtronic pacemaker problems, but it has not been confirmed whether the battery malfunction was a contributing factor.

CRT Pacemakers are implantable devices positioned under the skin and just below the collarbone. The devices are designed to assist the heart’s pumping action to treat fast, irregular, or slow heart rhythms, by applying small electric pulses to both sides of the heart to keep the left and right chambers beating in proper sync. The devices are also used to treat patients susceptible to heart failure by improving the body’s ability to pump blood and distribute oxygen.

The Medtronic InSync III pacemakers have been recalled due to the potential failure of the batteries to supply sufficient power for electric pulse therapies to the patient’s heart. Without the ability for the device to deliver electric pulse therapies, patients with heart disabilities may not be able to rely on the pacemaker in the event of a medical emergency, which could lead to serious injury and death.

According to the FDA, Medtronic sent an Urgent Medical Device Correction letter last month to all affected customers urging patients with implanted devices to meet with their healthcare providers immediately to re-evaluate follow-up frequency for better monitoring.

Medtronic announced in the notice that the issue cannot be mitigated by any sort of programming changes and due to the unpredictable nature, it is not possible to identify if a device is at a failing stage unless an emergency occurs, which could be too late.

The root cause of the battery issue is undetermined at this time, but Medtronic indicates that it believes it could be the result of unexpected high battery impedance.

Due to the company’s inability to correct the devices, Medtronic indicates that healthcare professionals should assess whether individuals should continue using the recalled devices under increased monitoring or have replacement surgery, depending on the patients’ health risks.

Of the 97,000 Medtronic InSync III pacemakers distributed on the market, an estimated 22,000 of the battery powered implantable CRT’s are reportedly still implanted in patients. Included among the 30 confirmed malfunction reports, several reports indicate the pacemakers had just been implanted within the last three or four years.

The recall includes InSync III implantable pulse generator pacemaker with model numbers 8042, 8042B, and 8042U. The devices were manufactured by Medtronic Inc., of Saint Paul, Minnesota where they were distributed for sale across the world, specifically nationwide in the U.S. to hospitals and healthcare providers. The recall includes exactly 96,787 units on the market.

Healthcare professionals are being asked to contact their patients immediately to evaluate corrective treatments, increased follow-up appointments and/or any other medically advised courses of action depending on the individual. Patients with questions or further concerns may contact Medtronic Patient Services at 800-551-5544 or Medtronic Technical Services at 800-505-4636.