December 4, 2020 – On December 3, Boston Scientific announced three advisories related to its Emblem S-ICD. They address the potentials for battery depletion, device damage due to electrical shorting, and lead fracture.
Background of Recall
On December 3, Boston Scientific announced three medical device advisories related to the Emblem S-ICD. Each advisory’s key aspects are addressed below. The company is releasing these simultaneously since some devices could be affected by more than one of the 3 advisories. To determine if a device is affected in any of these advisories, you can enter the model/serial number on Boston Scientific’s Device Lookup Tool.
Manufacturer Recommendations
The following was recommended for all three advisories:
- Monitor patients through LATITUDE patient management system per the 2015 HRS Consensus Statement on remote monitoring.
- Demonstrate and assess the patient’s ability to hear the beeping alert in clinic
- Repeat beeper demonstration in patients not followed by LATITUDE after an MRI which can affect the beeper volume
- Remind patients to promptly call if they hear beeping tones
- Perform a device follow-up every 3 months either remotely or in person
HRS Recommendations
HRS strongly encourages its members to become familiar with these 3 advisories and Boston Scientific’s recommendations for following affected patients.
A copy of A Dear Patient letter is available for download and dissemination.
HRS also encourages providers to discuss these issues in a shared decision making fashion with their patients to determine the best course of action for each individual patient that is affected.
Reporting Contact
Adverse reactions or quality problems experienced with the use of this product should be reported to Boston Scientific or to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit a report online at www.fda.gov/medwatch/report.htm.
- Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms.htm. Forms may be mailed or faxed. Follow instructions on form.
Topic
- Regulatory
- Regulatory Agencies
- U.S. Food and Drug Administration (FDA)
Resource Type
- Safety Alerts
Manufacturer
- Boston Scientific
Device Type
- ICDs & CRT-Ds
FDA Class
- Class I
Related Resources
Safety Alerts
Biosense Webster Advisory: Update to the Instructions for Use for VARIPULSE
March 26, 2025
Safety Alerts
Abbott Advisory: Manufacturing Defect Associated with Loss of Pacing for a Limited Subset of Assurity™ and Endurity™ Pacemakers
February 18, 2025
Safety Alerts
Philips Urgent Medical Device Correction: Mobile Cardiac Telemetry (MCT) or Event Diagnostic Service Processing
February 5, 2025