FDA MedWatch - EMBLEM S-ICD Subcutaneous Electrode (Model 3501) by Boston Scientific: Class I Recall - Due to Risk of Fractures

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: EMBLEM S-ICD Subcutaneous Electrode (Model 3501) by Boston Scientific: Class I Recall - Due to Risk of Fractures AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode because of increased risk of fractures at a specific point (distal to the proximal sense ring). If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats from cardiac arrest (tachycardia). A failed device may cause serious adverse events. Examples include injury or death, if cardiac arrest cannot be treated, or need for additional surgery to replace failed devices. There have been 27 complaints about this device issue and 26 reports of serious injuries. One death has been reported. For more information about this recall click on the red button "Read Recall" below. BACKGROUND:The EMBLEM S-ICD Subcutaneous Electrode Model 3501 is part of the Boston Scientific S-ICD System. The Boston Scientific S-ICD is an implantable cardioverter defibrillator that is intended to provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. These cardiac devices are implanted under the skin in the upper chest area. RECOMMENDATION: On December 2, 2020, Boston Scientific sent an Important Medical Device Advisory letter to all affected customers with recommendations for prompt identification of devices at risk for electrode body fracture. Recommendations were offered to help physicians and patients evaluate the risks of using affected devices compared to replacing them. Care for recalled devices at risk for failure was provided: Enroll and monitor patients through LATITUDE remote monitoring to detect any alerts or artifacts on the devices in between office device checks. Perform a system follow-up every three months by remote or in-office checks. Perform a chest radiography of the entire electrode length if there is a suspicion of a break. Demonstrate the device beeper to the patient during the next office visit. Evaluate the risk for life-threatening harm due to an electrode body fracture.  Replace any electrode that is shown to have breaks with signs like artifacts, high impedance alert, or X-ray results. Update medical Records with this letter for each patient with an EMBLEM S-ICD Subcutaneous Electrode (Model 3501). 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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