FDA MedWatch - EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System by Boston Scientific: Class I Recall - Due to Risk of Short-Circuit

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System by Boston Scientific: Class I Recall - Due to Risk of Short-Circuit AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology  ISSUE: Boston Scientific is recalling the EMBLEM S-ICD  system because a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high voltage shocks. If this happens during use, patients may experience less shock than intended or may not receive a shock at all. The device may also beep, not respond to a device check in, and issue battery alerts. A defibrillator with the manufacturing error may delay or prevent the device from delivering a lifesaving electrical shock to a person in cardiac arrest (tachycardia) and lead to serious injury or death. Additional surgeries may also be needed to replace failed devices. The manufacturer has received six complaints about this device issue. There have been no reports of injuries or deaths. For more information about this recall click on the red button "Read Recall" below. BACKGROUND: The EMBLEM S-ICD is part of the Boston Scientific S-ICD System. The Boston Scientific S-ICD is an implantable cardioverter defibrillator that is intended to provide electrical shock to stop dangerously fast heart rhythms and pacing for a short time after shocks if needed. These cardiac devices are placed under the skin in the upper chest area. RECOMMENDATION: In December 2020, Boston Scientific sent an Urgent Medical Device Advisory to all affected customers. The notice instructed customers to: Follow-up in the next 6 weeks and discuss this advisory with patients to ensure awareness, to review their individual clinical status and perspective, and to determine their individual risk status. Enroll and monitor patients through LATITUDE remote monitoring to detect any alerts or artifacts on the devices in between office device checks. Investigate any suspected indication of inability to interrogate, premature battery depletion, or prolonged charge time alerts.  Demonstrate the device beeper to the patient during the next office visit.  Evaluate the risk for life-threatening harm due to device malfunction. Replace any device suspected of exhibiting electrical overstress. Update medical records with this letter for each patient with an affected EMBLEM S-ICD.  Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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