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A company-initiated recall of two models of EMBLEM S-ICD (Boston Scientific) subcutaneous implantable cardioverter defibrillator pulse generators has been categorized as Class I by the US Food and Drug Administration (FDA), the agency announced today.
The FDA notes that the advisory, which was communicated to patients and doctors in December, applies to 2825 of the company’s S-ICD model A209 and MRI S-ICD A219 devices, methotrexate adverse reaction which were distributed from June to September 2019. The reason: “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 agency states.
“The manufacturer has received six complaints about this device issue. There have been no reports of injuries or deaths,” it says.
The announcement recommends a remote or in-office system check every 3 months for patients who have already been implanted with these devices, plus regular follow-up through the Boston Scientific LATITUDE remote monitoring network.
The FDA recall announcement is a sequel to one it made in early February that assigned Class I to a company-initiated recall of EMBLEM S-ICD leads due to an apparent heightened risk for fracture. There had been 27 reports of serious injuries, including death in one case, in association with the lead problem, the agency noted.
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