Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its EMBLEM S-ICD Subcutaneous Electrode (Model 3501).

The manufacturer has received 27 reports of electrode body fractures at a location just distal to the proximal sense ring. During onset of an electrode body fracture, some cases reported oversensing non-physiologic artifacts in stored episodes and inappropriate shock therapy in select programmed sense configurations. If the high voltage conductors fracture, an electrode will be unable to deliver defibrillation therapy and a high impedance alert will be initiated via programmer, LATITUDE (Home Monitoring System), and/or beeping tones.

According to the manufacturer, the cumulative occurrence rate for this specific electrode body fracture location is 0.2% at 41 months with a potential for life-threatening harm of 1 in 25,000 (0.004%) at 10 years. There has been a single reported patient death related to this behavior.

In addition, the manufacturer has also issued two medical device safety alerts involving:

• EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) with an elevated likelihood for early replacement (Boston Scientific Field Action Reference: 92400926-FA Rev D).
• EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) with a potential for electrical overstress during delivery of high voltage therapy (Boston Scientific Field Action Reference: 92628736-FA).

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 4 December 2020