What You Need to Know
- On December 3, 2020, Boston Scientific sent a Medical Device Alert letter warning doctors that EMBLEM S-ICD Subcutaneous Electrodes (Model 3501) were fracturing and putting the patient at risk of significant injuries.
- The Medical Device Alert includes 47,000 devices distributed worldwide since 2017.
- Devices that experience fracture may cause inappropriate shocking or prevent the patient from receiving necessary therapy. At least one person has died after their electrode fractured.
If you were implanted with an EMBLEM S-ICD Subcutaneous Electrode (Model 3501), you may be entitled to compensation. Complete the free case review form or call 800.887.8029 for a free and confidential consultation.
Boston Scientific Subcutaneous Electrodes (Model 3501) May Fracture and Cause Injury
The US Food & Drug Administration approved the EMBLEM S-ICD system in 2012. Boston Scientific promotes the EMBLEM S-ICD as the only subcutaneous implantable cardioverter defibrillator (ICD) that is designed to protect from injuries caused by certain cardiac events or complications with transvenous leads.
The S-ICD system generally consists of an implantable pulse generator and a subcutaneous electrode. The pulse generator creates the energy, and the subcutaneous electrode is the component that senses heart irregularities and delivers the therapy (i.e., defibrillation shocks).
On March 9, 2017, Boston Scientific received approval to begin selling the Subcutaneous Electrode (Model 3501) as part of the EMBLEM S-ICD system. Since then, more than 47,000 devices with the Subcutaneous Electrode (Model 3501) have been sold worldwide. And Boston Scientific has informed the FDA of 152 changes to the S-ICD system from the original application.
Medical Device Alert Letter
The December 3, 2020 Medical Device Alert letter warned doctors that some EMBLEM S-ICD Subcutaneous Electrodes (Model 3501) were reportedly fracturing and causing inappropriate shocks. Specifically, the letter identifies the following problem:
“During assembly of the EMBLEM S-ICD Subcutaneous Electrode, a small amount of adhesive is applied to a location just distal to the proximal sense ring. Over time, mechanical stresses on the electrode body at this location may create the potential for a fatigue crack to initiate from the outer lumen. This crack then propagates inward toward the center-oriented distal sense conductor, eventually resulting in a fracture of the first two-high voltage conductors.”
The Medical Device Alert warns that patients who experienced fractures to their Subcutaneous Electrode sensors may receive inappropriate shocks or the device may fail to deliver life-saving therapy. Inappropriate electric shocks can cause significant pain. In some situations, the patients receive no warning that the device fractured, raising concern that some may be at significant and immediate risk of serious injury, including death. Boston Scientific has reported that at least one person died after their device fractured.
TALK TO A LAWYER
If you were implanted with an EMBLEM S-ICD Subcutaneous Electrode (Model 3501), you may be entitled to compensation. Complete the free case review form or call 800.887.8029 for a free and confidential consultation.
