Medtronic Viva CRT-D and Evera ICD Battery Problems May Cause Device Failure

Problems with Medtronic’s Viva Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillators (ICDs) could result in rapid battery depletion, which has caused nearly 10% of the units to fail. 

Medtronic issued an urgent field safety notice last month for the Viva CRT-D and Evera ICD, indicating that at least 78 affected devices have a low resistance path in one of the circuits, which could quickly drain the battery.

Already, seven of the 78 devices have been confirmed to have failed, and Medtronic predicts another six will likely fail among the remaining population. The company notes that in case where the circuit became a problem, the battery depleted in seven days or less.

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

The failures of the ICD or CRT-D units presented clinically during doctors’ visits, as one or more electrical resets, a lack of pacing or defibrillation therapy output, no telemetry, or a programmer screen display that warns of “SERIOUS DEVICE MEMORY FAILURE.” Medtronic warned that patient audible alerts and CareAlerts may not be reliable.

Patients who suffered device failures suffered symptoms including:

  • Shortness of breath
  • Pocket heating
  • Low heart rate
  • Early device explant

The manufacturer indicates that no deaths have been reported in connection with the Medtronic Viva CRT-D and Evera ICD Battery Problems, however doctors have been advised to tell patients to seek medical attention if they begin to suffer symptoms like fainting or lightheadedness, or if they hear an audible patient alert. Doctors should consider device replacement for those patients who are pacemaker-dependant or at higher risk of Ventricular Tachycardia or Ventricular Fibrillation.

The company also provided a list of recommendations for patients with lower risks. The notice included a complete list of affected product names, models and serial numbers.

Image Credit: Image via Ken Wolter / Shutterstock.com

1 Comments

  • lelaOctober 28, 2017 at 5:35 am

    well my husband died 8-15-16 after implant 12-15 on going problems from the week after implant was done and he had burning complaints in implant pocket shortness of breath screaming to me he could not breath !!!!!HE had a heart rate of 22 beats or less no blood pressure.... He died !!!!!!!!! I always have felt it was the ICD called doctors after he died ..... seeing recall I knew battery wasn'[Show More]well my husband died 8-15-16 after implant 12-15 on going problems from the week after implant was done and he had burning complaints in implant pocket shortness of breath screaming to me he could not breath !!!!!HE had a heart rate of 22 beats or less no blood pressure.... He died !!!!!!!!! I always have felt it was the ICD called doctors after he died ..... seeing recall I knew battery wasn't working right.

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

AT&T Data Breach Lawsuits Seek Damages for 70M Customers Whose Information Was Released
AT&T Data Breach Lawsuits Seek Damages for 70M Customers Whose Information Was Released (Posted today)

AT&T faces a growing number of data breach class action lawsuits, which plaintiffs say should be consolidated before one federal judge for coordinated pretrial proceedings.

Fairness of Philips CPAP Recall Settlement Being Evaluated By MDL Judge
Fairness of Philips CPAP Recall Settlement Being Evaluated By MDL Judge (Posted yesterday)

A federal judge has held a fairness hearing for a proposed Philips CPAP class action lawsuit settlement, which seeks to resolve claims that consumers suffered economic damages due to the massive recall over toxic sound abatement foam.