Safety Advisory Regarding A Subset of Boston Scientific EMBLEM™ S-ICDs

On August 21, 2019, Boston Scientific released an Urgent Medical Device Advisory regarding the performance of approximately 400 Model A209/A219 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICD) worldwide, manufactured in July 2017.  

Safety Alerts
U.S. Food and Drug Administration (FDA)


On August 21, 2019, Boston Scientific released an Urgent Medical Device Advisory regarding the performance of approximately 400 Model A209/A219 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICD) worldwide, manufactured in July 2017. This subset of devices (approximately 0.7% of the 56,000 EMBLEM™ S-ICDs implanted worldwide) exhibits an elevated likelihood (19% at 3 years) of an electrical component causing accelerated battery depletion. The devices within this advisory subset are no longer available for implant. 
  
Boston Scientific’s recommendations for managing the approximately 400 patients are detailed in its letter to the field. A patient education letter is provided for use by clinicians to facilitate discussions with affected patients. A device lookup tool is also available online. Affected devices are expected to have 21 days of function after reaching ERI. To date, no serious injuries or deaths have been reported in conjunction with this advisory. Other than this subset of approximately 400 patients (identifiable by serial number), all other patients with EMBLEM™ S-ICDs are currently unaffected by this advisory. 
 

Remote monitoring for this subset of EMBLEM™ S-ICD patients is of critical importance and represents standard practice for all patients with CIEDs. Patients with affected EMBLEM™ S-ICDs should be enrolled and regularly monitored in LATITUDE™ to facilitate prompt detection of ERI/EOL during the interval between in-office device checks. The 2015 HRS Expert Consensus Statement on Remote Interrogation and Monitoring of CIEDs gives a Class I recommendation (level of evidence A) to implementing a strategy of remote CIED monitoring and interrogation, combined with at least annual in person evaluations. More frequent in person follow-up is recommended for those who cannot undergo remote monitoring, and audible alert tones will signal development of ERI/EOL status in affected devices.


If there are additional questions, please contact your Boston Scientific representative, customer service (1-800-CARDIAC), or regional technical services included in the Boston Scientific advisory.