Safety Advisory Regarding Medtronic EnTrust ICDs

On June 21, Medtronic announced an urgent medical device recall affecting approximately 2,770 (209 confirmed active in the U.S.) EnTrust ICDs due to the potential for loss of high voltage and ATP therapy as they near elective replacement indicator (ERI) stage. This model was last manufactured in 2010. Twenty-five devices have experienced a charge time out due to reaching End of Life (EOL) with no (21) or abbreviated (4) ERI stage. To date, there have been no patient deaths or complications due to this issue.

Medtronic recommends that physicians consider an in-office patient follow-up as soon as possible with affected patients to assess battery status and perform some reprogramming and testing. If the battery voltage is 2.64V or less (nominal ERI being 2.61V), prophylactic ICD generator replacement is recommended. If the battery voltage is greater than 2.64V, it is recommended to reprogram the Auto-Cap Formation Interval value to "6", and to conduct a manual high voltage capacitor charge and assess the charge time. If the charge time is greater than or equal to 16 seconds or "EOL" alert appears, then ICD generator replacement is recommended. If the charge time is less than 16 seconds, then routine 3 month follow-up is advised. Detailed advice to physicians and healthcare professionals is provided in the urgent medical recall notification.

Medtronic has contacted those healthcare professionals who have one or more patients implanted with an affected device and has published a complete list of model and serial numbers.

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.