Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery

Publication Date: March 19, 2018

Medtronic recommends that prophylactic device replacement be considered only for patients whose clinical history indicates prior need for high-voltage therapy, and/or those who are pacemaker-dependent. Medtronic has contacted those healthcare professionals who have one or more patients implanted with an affected device. The communication also includes a list of the affected models.

This notification extends the Food and Drug Administration (FDA) recall on February 26, 2018 of 48 Medtronic devices that were identified to have a defect in the manufacturing process that could lead to an out-of-specification internal gas environment. This may introduce a risk for internal arcing during high-voltage charging, resulting in immediate and permanent loss of device functionality, including pacing and high-voltage therapy. Within this lower-risk subset of 752 devices, if the device delivered the maximum number of shocks until battery depletion, Medtronic estimates 0.5% of these devices would experience arcing during high-voltage charging, with failure occurring within the first 2 high-voltage charges in 0.18% of the devices.

For additional information, healthcare professionals should contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636. Patients can call the Medtronic Patient Services at 800-551-5544.

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.

• Complete and submit a report online at www.fda.gov/medwatch/report.htm.
• Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms.htm. Forms may be mailed or faxed. Follow instructions on form.

2016 Safety Alert- Medtronic Recalls 48 Individual ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery 

On February 26 2016, the Food and Drug Administration (FDA) announced a recall of 48 individual Medtronic ICDs and CRT-Ds, identified by the devices' serial numbers. For these 48 individual units, the Class I recall recommends that the physician and the patient strongly consider prophylactic device replacement for patients who have been implanted with one of the affected devices. HRS has communicated with Medtronic to verify that the problem has been addressed. On January 22, 2018, Medtronic notified all physicians whose patients had the devices.

Medtronic has identified a defect in the manufacturing process that caused an out of specification gas mixture inside the device that may prevent the device from delivering an electrical shock. One patient with an affected ICDexperienced sudden cardiac arrest and was revived via an external defibrillator. Medtronic determined that 48 individual devices made in a single manufacturing location and only distributed in the United States were affected.

Customers who have questions or need additional information or support regarding this recall should contact Medtronic Technical Services at 800-723-4636. Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time)