Safety Advisory: Boston Scientific first generation S-ICD system SQ-RX™ Model 1010 Pulse Generators (PG)

Publication Date: November 5, 2018

On November 5 2018, Boston Scientific released a product advisory related to accelerated battery depletion and a shortened replacement interval observed in some of the first generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system SQ-RX™ Model 1010 Pulse Generators (PG) (acquired from Cameron Health Incorporated). There have been no reports of related injury. This safety risk is not applicable to the EMBLEM™ MRI or EMBLEM S-ICD.

As this pulse generator model is not capable of remote patient management, Boston Scientific recommends that in-clinic device checks be performed every 3 months, which is consistent with the SQ-RX Model 1010 PG User Manual. If the patient’s last visit was over 3 months ago, a follow-up visit should be scheduled within thirty days. It is also recommended that healthcare providers demonstrate the beeper tone to the patient by applying a magnet over the PG at the next office visit.

The potential for life-threatening harm is greater for patients who have experienced life-threatening ventricular arrhythmias, patients not followed every 3 months, and/or patients who are unable to hear beeping tones. Boston Scientific’s recommendations are further detailed in its letter to the field.

Any adverse reactions or quality problems experienced with the use of this product should be reported to Boston Scientific and 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.