Certain models of St. Jude Medical, Inc.’s defibrillators were recalled in October 2016 (recall notice). Defibrillator models including the Fortify, Unify, and Assura ICDs and CRT-Ds were recalled due to reports of rapid battery failure caused by deposits of lithium in the battery, leading the devices to short circuit. The FDA and St. Jude Medical are alerting patients and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts.
To date, 841 devices were returned for analysis due to premature battery depletion. In addition to the two reported deaths, 10 people have reported fainting and 37 have reported dizziness from devices that could not provide adequate pacing therapy due to battery depletion. The recalled St. Jude devices were manufactured before May 2015 and include the following ICD and CRT-D models:
- Fortify VR
- Fortify ST VR
- Fortify Assura VR
- Fortify Assura ST VR
- Fortify DR
- Fortify ST DR
- Fortify Assura DR
- Fortify Assura ST DR
- Unify Quadra
- Unify Assura
- Quadra Assura
- Quadra Assura MP
Click here for the recall notice and a complete list of the affected St. Jude devices.
Patients are advised by the FDA to contact their physician if they feel a vibratory alert and to register for home monitoring to alert their physician. If symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath occur, patients are advised to seek medical attention immediately.
Likewise, health care providers are asked not to implant unused affected devices and to talk with their patients who have affected devices about the risk of battery depletion. Health care professionals are to continue to conduct follow-up visits with patients who are implanted with affected devices and to immediately replace the device, should an ERI alert occur.
On April 12, 2017, the FDA sent St. Jude a warning letter regarding the defibrillator issues. The FDA said St. Jude officials had for years systematically underestimated the true risk to patients by basing their evaluations only on “confirmed” cases of battery failures, and disregarding cases in which battery shorts may have been involved. Even when the outside company that supplies St. Jude’s defibrillator batteries provided evidence for what was causing the problem, St. Jude officials concluded the cause of the failures was unconfirmed.
If you or a loved one have one of the recalled St. Jude devices, contact us today for a free legal consultation. Call us toll-free at: (800) 351-8588 or click here to provide us with your contact information and have a representative from our law firm call you back.