Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued an alert concerning Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs), manufacturer by Medtronic. The affected products are identified as follows:

• Product Codes: NIK, LWS
• Serial Numbers: Refer to the FDA website.
• Manufactured from 13 July 2013 to 8 August 2017.

The manufacturer is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient's heartbeat or revive a patient in cardiac arrest.

According to the manufacturer, the delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient's heart whose heartbeat is too slow could result in serious injury and/or death.

The affected customers are asked to take to following actions:

• Consider Prophylactic device replacement for patients who have been implanted with one of the affected devices.
• Contact their Medtronic sales representative for terms and conditions for device warranties.
• Review the recall notice and ensure appropriate staff is aware of the notice.

The manufacturer will offer a supplemental device warranty for affected devices.

For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm598198.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 February 2018