Our team of attorneys is currently investigating claims that the EMBLEM S-ICD Subcutaneous Electrode (Model 3501) has an increased risk of fracture after implantation, which can 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
EMBLEM is a subcutaneous implantable cardioverter defibrillator (S-ICD) manufactured by Boston Scientific. Surgeons have been implanting the EMBLEM S-ICD in US patients from June 2017 to December 2, 2020. The EMBLEM S-ICD was designed to treat patients with abnormal heart rhythm (arrhythmia). 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 December 2, 2020, Boston Scientific sent out an Important Medical Device Advisory letter, warning of the risk of EMBLEM S-ICD fracture. On February 10, 2021, the FDA issued a Class I recall of the EMBLEM S-ICD. A Class I Recall is the most serious type of recall, meaning use of the device may cause injuries or death. The recall reports that Boston Scientific received 27 complaints of EMBLEM S-ICD fractures, with 1 death and 26 serious injuries. And the recall warns that EMBLEM S-ICD fractures could be dangerous because once an EMBLEM S-ICD fractures it may no longer be able to treat abnormal heart rhythm.
The recall recommends that patients with an EMBLEM S-ICD implant should:
- Enroll in LATITUDE remote monitoring and conduct weekly checks
- Attend checkups with a physician every 3 months
- Undergo a chest radiography if there is a suspicion of fracture
- Tell a physician if the device makes beeping noises or sends out a shock
- Surgically remove the EMBLEM S-ICD if it fractures
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.