—#168782

Product

The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110042
Affected lot / code info: SQ-RX Pulse Generator Model 1010

Why it was recalled

Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Boston Scientific, sent an "Important Medical Device Information" letter to customers on November 5, 2018 by hand, email via our sales representatives or Federal Express or Courier. The letter described the product, problem and actions to be taken. We will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/product-advisories.html. The customers were instructed to do the following: Your doctor has been notified to look for this possible change, so please go to all scheduled defibrillator checks and clinic visits. As always, if you or your family hear beeping from your device, please contact your heart clinic as soon as possible. Your doctor can confirm your ability to hear and recognize this sound during an appointment. If you have additional questions regarding this information or would like to report a clinical event, please contact your Boston Scientific representative or Technical Services, or the Recall Contact at 651-582-3494 or email: Heather.Young@bsci.com.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

Timeline

Recall initiated: 2018-11-01
Terminated: 2019-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168782. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.