Safety Warning: St. Jude Defibrillators
The FDA has issued a Safety Communication that warned patients, doctors, and caregivers that St. Jude’s Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) may experience premature battery depletion. St. Jude reported that it is aware of two people who died as a result of rapid battery depletion, and an additional 841 devices are confirmed to have the problem that causes defibrillators to rapidly lose their power. The problem affects hundreds of thousands of people implanted with St. Jude defibrillators worldwide.
- 4/13/2017: St. Jude Medical played down defibrillator failures for years, nytimes.com
- 4/12/2017: FDA sends St. Jude a warning over two high-profile device issues, startribune.com
- Read the FDA Warning Letter
On October 11, 2016, St. Jude sent an “Important Medical Device Advisory” letter to doctors, warning that several of St. Jude’s ICD and CRT-D devices have experienced premature battery depletion. The “Dear Doctor” letter reported that the following models manufactured before May 2015 are affected:
- Fortify Assura
- Quadra Assura
- Quadra Assura MP
- Unify Asssura
- Unify Quadra
St. Jude’s letter warns that, “349,852 affected devices are still in service worldwide and, therefore, potentially at risk.” Call us at 1.800.877.8029, or fill out our free case review form and we can help you navigate the next steps.
Did St. Jude know there was a problem and failed to warn doctors and patients?
According to a recent report, a 2014 journal first disclosed that the batteries in certain St. Jude defibrillators may be susceptible to rapid depletion, leaving the medical community questioning whether St. Jude responded quickly enough to a situation that has claimed the lives of at least 2 people. According to Dr. Robert Hauser, a Minneapolis-based cardiologist, St. Jude’s decision not to warn patients at an earlier date was “disappointing, but not surprising.”
How We Can Help
If you were implanted with a St. Jude defibrillator, our Medical Device Safety Team can help you determine whether you received one of the faulty defibrillators. You should also contact your doctor to address any immediate concerns. 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 we welcome any questions you may have.