FDA SAFETY COMMUNICATION: MEDTRONIC PACEMAKERS

On May 7, 2019, the FDA issued a Safety Communication alerting patients, caregivers, and doctors about a potentially serious problem involving more than 131,000 Medtronic pacemakers sold in the US.

According to the FDA’s announcement, the batteries in certain Medtronic pacemakers may drain more quickly than expected because of electrical shorts caused by cracks in the device’s capacitor. The FDA received reports of multiple cases involving Medtronic pacemakers that had fully drained because of cracked capacitors, without any warning to the patients or health care providers. Medtronic issued a statement claiming that the cracks occur during the manufacturing process.

 The affected Medtronic implantable pacemaker and cardiac resynchronization therapy pacemaker (CRT-P) device have been implanted since 2017 and include the following models:

  • Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
  • Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
  • Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
  • Serena models: W1TR02, W1TR05, W4TR02, W4TR05
  • Solara models: W1TR03, W1TR06, W4TR03, W4TR06

If you or a family member have been implanted with a Medtronic pacemaker since 2017, call us at 1.800.887.8029, or fill out our free case review form, and we can help you determine if you were implanted with one of the affected devices.

How We Can Help

Most importantly, you should contact your doctor to address any immediate concerns.

If you or a family member were implanted with a Medtronic pacemaker or CRT-P since 2017, our Medical Device Safety Team can help you determine the next steps you may wish to consider. Please call us toll-free at 1.800.887.8029 for a free consultation or fill out an online free case review form. Zimmerman Reed is experienced in handling defective medical device cases and our team welcomes any questions you may have.