In October 2016, St. Jude Medical issued an ICD & CRT-D battery recall and correction, due to a battery depletion issue that could affect may of its Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillator devices. When the announcement was made, the battery problem had already been linked to two deaths and numerous other adverse events.
The nationwide law firm of Bernstein Liebhard LLP is now investigating St Jude Medical’s ICD & CRT-D battery recall. If you or a loved one were affected by this action, please call (888) 994-5118 to learn more about your legal rights.
St. Jude Medical’s Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) products are indicated to treat patients with bradycardia (heart beats to slow) or tachycardia (to fast), as well as individuals who require coordination to treat heart failure. The devices are implanted under the skin in the upper chest, and attached to the heart muscle via thin wires called leads. Once in place, they provide pacing for slow heart rhythms, as well as electrical shock or pacing to stop dangerously fast heart rhythms.
On October 11, 2016, St Jude announced a recall and correction for many of its ICDs and CRT-D products due to a risk of premature battery depletion. If the battery is depleted prematurely, the ICD or CRT-D will not be able to provide needed shock therapy.
Devices affected by this action were manufactured prior to May 2015, and include:
According to the U.S. Food & Drug Administration (FDA), of the 398,740 ICDs and CRT-Ds sold worldwide, 841 have been returned to St. Jude for analysis due to premature battery depletion. Adverse events related to these issues included:
The FDA also pointed out that battery depletion may not always be reported to the manufacturer, therefore the true number of ICDs and CRT-Ds with this issue is not known. However, 349,852 affected devices remain actively implanted in patients worldwide.
On October 24, 2016, the FDA designated St. Jude Medical’s action Class I, the most serious classification possible. The agency only declares Class I recalls when the use of a device may cause serious injuries or death. Read More
Patients with St. Jude Medical ICDs and CRT-Ds can visit the company’s website to determine if their device is affected by this recall. The FDA and St. Jude have advised patients, as well as their caregivers and physicians, to respond immediately to any Elective Replacement Indicator (ERI) alert issued from an affected implant. “Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement,” the FDA warned. “Some batteries have run out within 24 hours of the patient receiving an ERI alert.”
According to the FDA alert, affected ICDS and CRT-Ds may be programmed to deliver a vibratory patient alert when the battery has reached ERI. The agency has also recommended that St. Jude Medical’s Merlin@home monitoring system be used to monitor battery status. However, these mitigations may not be sufficient for all patients. In such cases, health care providers should consider whether elective device replacement is warranted for their ICD and CRT-D patients.
The FDA, in conjunction with the U.S. Department of Homeland Security, continues to investigate recent allegations that St. Jude cardiac devices, including Merlin@home, may be vulnerable to hackers. The allegations were made in August 2016 by the Muddy Waters investor group and a research firm called MedSec Holdings.
“Despite the allegations, at this time, the FDA strongly recommends that the Merlin@home device be used to monitor the battery for these affected devices because the benefits of continued patient monitoring and the life-saving therapy these devices provide greatly outweighs any potential cybersecurity vulnerabilities,” the agency said in its statement.
Patients injured as a result of a prematurely depleted ICD or CRT-D battery, as well as those who require replacement of a St. Jude cardiac device due to this issue, may be entitled to compensation. To obtain a free, no-obligation legal review of your case, please contact Bernstein Liebhard LLP today by calling (888) 994-5118.
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