Longevity Estimator Software Error for Subset of Medtronic CIEDs

On October 3, 2019, Medtronic began notifying healthcare professionals that a subset of pacemakers and implantable cardioverter defibrillators (including CRT and Micra TPS devices) manufactured between October 2018 and April 2019 may display an inaccurately short estimate of battery longevity. 

Safety Alerts
U.S. Food and Drug Administration (FDA)

On October 3, 2019, Medtronic began notifying healthcare professionals that a subset of pacemakers and implantable cardioverter defibrillators (including CRT and Micra TPS devices) manufactured between October 2018 and April 2019 may display an inaccurately short estimate of battery longevity. Importantly, the actual battery longevity is not affected by this problem. 
  
A software patch to correct the erroneous longevity estimate is anticipated to be available by mid-2020. Because the battery longevity calculation is performed by the Medtronic programmer and/or CareLink remote monitoring system (it is not calculated by the Cardiac Implantable Electronic Device [CIED] generator), software updates for individual patient CIEDs will not be needed. Affected CIEDs will continue to display an accurate battery voltage and charge time, and retain the ability to appropriately trigger the Recommended Replacement Time (RRT) indicator. The cause of the inaccurate longevity estimate is explained in Medtronic’s advisory to healthcare professionals.
 

Approximately 53,100 CIEDs worldwide out of 1.23 million distributed from the identified device families are susceptible to display inaccurate longevity. Through September 2019, Medtronic reports that there have been only three (3) complaints and zero (0) serious adverse events or deaths.
  
Patients and clinicians may determine if a specific pacemaker or ICD is affected by looking up the serial number on Medtronic’s Product Performance website or by contacting Medtronic technical support (tshelp@medtronic.com; Tachycardia Devices 800-723-4636; bradycardia devices 800-505-4036). 
  
Medtronic provides detailed patient management recommendations in the healthcare professional notification letter. Prophylactic CIED replacement is not recommended, as device functionality, battery voltage, and the RRT indicator are not affected by the inaccurate longevity estimate. 
  
Any adverse events or quality problems experienced with the use of any CIED should be reported to Medtronic and the FDA MedWatch Safety Information and Adverse Event Reporting Program.

Medtronic's Advisory on CFx Longevity Estimator Software Error

Reporting to Medtronic

Healthcare professionals can contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636 (tachycardia devices) or 800-505-4036 (bradycardia devices).