CASE ALERT: EMBLEM S-ICD Model A209 and Model A219 Lawsuits
Our team of attorneys is currently investigating claims that the EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) Model A209 and Model A219 have a manufacturing process which may allow moisture to get inside the defibrillator and cause a short-circuit, which may cause serious injuries or death.
Were you implanted with an EMBLEM S-ICD? Call ASK LLP today at (877) RING ASK (877-746-4275) for a free case evaluation.
What We Know About the EMBLEM S-ICD Model A209 and Model A219
EMBLEM S-ICDs are manufactured by Boston Scientific. Surgeons implanted the EMBLEM S-ICD Model A209 and Model A219 in US patients from June 1, 2015 to September 30, 2019. The EMBLEM S-ICD was designed to treat patients with abnormal heart rhythm (arrythmia). Abnormal heart rhythm can cause the heart to stop beating (cardiac arrest), which can cause brain damage or death. A properly functioning EMBLEM S-ICD regulates abnormal heart rhythms by sending out electric shocks.
On June 29, 2017, the FDA issued a Class II recall of the EMBLEM S-ICD Model A209, warning that the device can deliver an atypical amount of energy due to memory corruption inside the device. On December 2, 2020, Boston Scientific sent out an Important Medical Device Advisory letter, warning that EMBLEM S-ICDs Model A209 and Model A219 have an elevated likelihood of battery depletion. On February 19, 2021, the FDA issued a Class I recall of the EMBLEM S-ICD Model A209 and Model A219, warning that they can short circuit due to a manufacturing defect. The recall reports that Boston Scientific already received 6 complaints about this issue. And the recall warns that EMBLEM S-ICD short circuits could be dangerous because once an EMBLEM S-ICD short circuits it may delay or prevent treating abnormal heart rhythm.
The recall recommends that patients with an EMBLEM S-ICD Model A209 or Model A219 implant should:
- Attend a checkup with a physician in the next 6 weeks
- Attend checkups with a physician every 3 months via remote or in-office appointment
- Enroll in LATTITUDE remote monitoring and tell their clinic if they are unsuccessful in interrogating their device
- Have a physician investigate any suspected indication of inability to interrogate, premature battery depletion, or prolonged charge time alerts
- Have a physician demonstrate how to use EMBLEM S-ICD beeper at next appointment
- Have a physician repeat demonstration of how to use EMBLEM S-ICD beeper after every MRI scan, for patients not monitored by LATTITUDE
- Tell a physician if the EMBLEM S-ICD makes a beeping noise, sends out a shock, or if any LATTITUDE communicator transmissions are unsuccessful
- Tell their clinic if they experience any new or unexpected symptoms suspicious for a ventricular tachyarrhythmia and, if applicable, perform remote interrogation via LATTITUDE
- Surgically remove the EMBLEM S-ICD if it is suspected of exhibiting electrical overstress
Recoverable Compensation in an EMBLEM S-ICD Lawsuit
If you or a loved one were implanted with an EMBLEM S-ICD, then you may be eligible to participate in a lawsuit against EMBLEM S-ICD’s manufacturers and sellers. If you hire ASK LLP, we may seek the following damages for you:
- Past and future medical expenses
- Past and future pain and suffering
- Past and future wage loss
- Past and future loss of earning capacity
- Past and future loss of enjoyment of life
- Punitive damages, if justified
CALL TODAY! If you have been implanted with an EMBLEM S-ICD, you might be entitled to compensation. Call ASK LLP at (877) RING ASK (877-746-4275) for a free case evaluation.
Why You Should Choose ASK LLP
When you get hurt after using a medical device, you may not know what to do. After all, the medical device industry is a large and powerful one. We are here to help. Our experienced legal team has a strong track record of fighting—and winning—medical device cases. If you hire us, know that we will fight tirelessly to get you the best possible result.