The Boston Scientific Recalls Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
In June 2023, Boston Scientific announced the recall of its Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD). According to Boston Scientific, there is an issue with the device which can cause it to become disabled for a 24-hour period. Boston Scientific launched a software update to address a “rare, transient, sensing behavior” that could cause the device to become disabled. The device acts as a defibrillator to help stop the heart from beating too quickly during a cardiac event like a heart attack.
According to Boston Scientific, there have been 3 known incidents with the device out of 136,000 S-ICDs implanted in patients. In each case, the S-ICD devices remained “in service” and no patients reported being injured.
Boston Scientific recommends that patients with their S-ICD devices at their next scheduled follow-up.
Understanding the problem
According to Boston Scientific, the device sends low-energy pulses every 3 days to test the system’s impedance measurement. During the test, sensing is momentarily disabled to prevent non-cardiac artifacts from being over-sensed by the device or displayed on the S-ECG. If telemetry from the communicator is initiated within a 700 ms interval during the automatic system impedance check, the impedance measurement will stop and be postponed for a 24-hour period. During this period, sensing will be temporarily disabled until the next scheduled impedance measurement is performed.
The recent software update prevents the postponement of the system impedance measurement so sensing resumes as intended in approximately one cardiac cycle.
Potential for injury
Essentially, a glitch in the software causes the device to stop working for 24 straight hours. While the problem is rare, and no injuries have been reported, it’s also true that the three patients who had their devices malfunction got lucky. If they were to suffer a cardiac event during the 24-hour period when the device was disabled, the device would not deliver the shock treatment the heart needs to continue beating.
The device operates by stabilizing your heartbeat during a cardiac event. The worst-case scenario for such a device would be that a patient died of a heart attack because the device failed to work properly. Alternatively, the patient could suffer a significant injury due to a heart attack if the device were disabled when one occurred.
Product liability lawsuits
Boston Scientific claims there are three reports of device failure with no injured patients. However, if a patient were to be injured because the device failed, Boston Scientific would be on the hook to pay out a personal injury or wrongful death claim. Patients who suffer injury due to the failure of a medical device can file a lawsuit against the company that manufactured it. Such lawsuits are common and many medical device manufacturers have faced lawsuits over the failure of their devices.
Talk to a Florida Product Liability Lawyer Today
Halpern, Santos & Pinkert represents the interests of plaintiffs in product liability claims against medical device manufacturers. Call our Florida personal injury attorneys today to schedule a free consultation, and we can begin investigating your injuries right away.
Sources:
bostonscientific.com/content/dam/bostonscientific/quality/documents/Recent%20Product%20Advisories/2023%20July%20EMBLEM%20Physician%20Advisory%20Letter%20US.pdf
accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=202476#:~:text=There%20is%20a%20potential%20for,for%20a%2024%2Dhour%20interval.
